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Regenerative medicine is a way of treating injured and diseased human tissue by using laboratory-grown or therapeutically-induced human tissue as a replacement. As such, astounding new advancements in the ability to repair or replace damaged human tissue and organ functions are being made. Whereas before, remedies for damaged tissue or organ functions due to congenital deformities, injuries, diseases or simple wear-and-tear relied upon either the body's ability to repair itself (or not), or a surgeon's skilled hands. Now, the area of regenerative medicine promises to revolutionize humanity's ability to remediate countless physical maladies that have perpetually afflicted humans and other animals. Compared to a select few life forms--like the starfish--man-made solutions for tissue repair and organ replacement haven't come close to nature's solutions. And where there once was no solution even offered by nature, researchers are now at the cusp of overcoming such limitations by literally regrowing damaged tissue and restoring organ functions through the use of tissue engineering and stem cell therapy. This is the promise of regenerative medicine. This TriMark Publications report discusses the current state of regenerative medicine. The study provides a thorough overview of regenerative medicine sector together with analyses of the funding trends, intellectual property, market opportunities, therapeutic pipeline, research collaborations, partnership activities, and guidelines for establishing new ventures. The report enables the reader gain in-depth knowledge about ongoing tissue engineering and stem cell therapy research programs carried out in universities and other research centers. Moreover, this analysis profiles the leading companies developing regenerative medicine solutions.

1. 1. Overview 17
2. 1.1 Statement of Report 17
3. 1.2 Scope of this Report 19
4. 1.3 Methodology 19
5. 1.4 Executive Summary 20
7. 2. Regenerative Medicine: An Overview of Segments 22
8. 2.1 Tissue Engineering 22
9. 2.1.1 Tissue-Engineered Skin 23
10. 2.1.2 Tissue-Engineered Cartilage 23
11. 2.1.3 Tissue-Engineered Bone 23
12. 2.1.4 Tissue-Engineered Peripheral Nerves 23
13. 2.1.5 Tissue-Engineered Cornea 24
14. 2.1.6 Tissue-Engineered Blood Vessels 24
15. 2.2 An Overview of Tissue Engineering and Regenerative Medicine (TERM) 24
16. 2.2.1 Tissue-Engineered Products and Their Applications 25
17. 2.2.1.1 Skin, Cartilage, Bone and Urological Applications 26
18. 2.2.1.2 Cardiovascular Applications 26
19. 2.2.1.3 Neurological Applications 27
20. 2.2.1.4 Pancreas, Liver and Kidney Applications 27
21. 2.2.1.5 Ophthalmic Applications 28
22. 2.2.1.6 Dental Applications 28
23. 2.2.1.7 Autologous and Allogeneic Products 28
24. 2.2.2 Geographic Distribution of TERM Firms in the Five Focus Countries 28
25. 2.3 Cell Therapy 31
26. 2.3.1 Number of Patients Treated between 1988 and 2010 by Regenerative Medicine Therapies 33
27. 2.3.2 Cell Culture Products 34
28. 2.3.2.1 In vitro Test Kits 35
29. 2.3.2.2 Suppliers of Cells and Tissues 36
30. 2.3.2.3 Suppliers of Culture Media and Reagents 37
31. 2.3.2.4 Equipments for Stem Cell Research 37
32. 2.3.2.5 Computer Software for Stem Cell Research 38
33. 2.3.3 Overall Picture of Cell Therapy Industry 40
34. 2.3.3.1 The Size of Cell Therapy Industry 40
35. 2.3.3.2 The Age, Size and Location of Firms 41
36. 2.3.3.3 Technology and Disease Focus 43
37. 2.3.4 Cell Therapy Products and Companies 43
38. 2.3.4.1 First Generation (Non-Stem Cell-based) Primary Products 45
39. 2.3.4.2 Second Generation (Stem Cell-based) Primary Products 46
40. 2.3.4.3 Secondary Products 46
41. 2.3.4.4 Products in Development 47
42. 2.3.5 The Disease Focus of Clinical Trials 47
43. 2.3.5.1 Stem Cell Industry Pipeline 48
44. 2.3.6 Industry Collaboration in Stem Cell Space 50
45. 2.3.6.1 Commercial Success in Stem Cell Industry 50
46. 2.3.6.2 Major Shift to Stem Cells from Non-Stem Cell Technologies 51
47. 2.3.6.3 Challenges to Commercial Development of Cell Therapies 51
48. 2.3.6.4 Partnership of Stem Cell Companies with Large Pharmaceutical Companies 53
49. 2.3.6.5 Strategic Approaches for Cell-based Companies 53
50. 2.3.6.6 The Need for Support from Large Pharmaceuticals 55
51. 2.4 Scaffolding Biomaterials 55
52. 2.4.1 Biomaterial Scaffolds in Regenerative Medicine 56
53. 2.5 Growth Factors 58
55. 3. Regenerative Medicine: The Next Evolution of Medical Treatments 60
56. 3.1 Scope of this Chapter 60
57. 3.2 Need for Regenerative Medicine 60
58. 3.3 Current State of Regenerative Medicine 60
59. 3.4 Future of Regenerative Medicine 61
60. 3.5 Number of Products in Pipeline 61
61. 3.6 Projected Timeline for Regenerative Medicine 65
62. 3.7 Regenerative Medicine Products in the Market 66
63. 3.7.1 Medtronic's Infuse Bone Graft and the LT-Cage Device 66
64. 3.7.2 Genzyme's Carticel 67
65. 3.7.3 Stryker's OP-1 68
66. 3.7.4 Osyris/Nuvasive's Osteocel 68
67. 3.7.5 RTI's Spinal Implants 69
68. 3.7.6 Organogenesis' Apligraf 69
69. 3.7.7 Advanced BioHealing's Dermagraft 70
70. 3.7.8 Integra's Bilayer Matrix Wound Dressing 70
71. 3.7.9 LifeCell's Alloderm 70
72. 3.7.10 Cytori Therapeutics' Celution 71
73. 3.8 Other Products of Importance in Regenerative Medicine 72
74. 3.8.1 Tissue-Engineered Wound Healing Products 72
75. 3.8.1.1 Oasis 73
76. 3.8.1.2 Permacol 73
77. 3.8.1.3 EZ-Derm 73
78. 3.8.1.4 Matriderm 73
79. 3.8.1.5 TransCyte 74
80. 3.8.1.6 ICX-SKN 74
81. 3.8.1.7 OrCel 75
82. 3.8.1.8 Epicel 75
83. 3.8.1.9 Myskin 75
84. 3.8.1.10 VCT01 76
85. 3.8.2 ICX-TRC-Hair Regeneration Therapy 76
86. 3.8.3 Cartilage Regeneration 76
87. 3.8.3.1 Novocart 76
88. 3.8.3.2 BioSeed-C 76
89. 3.8.3.3 BioSeed-Oral Bone 77
90. 3.8.3.4 Chondrotissue 77
91. 3.8.3.5 co.don Chondrotransplant 77
92. 3.8.3.6 co.don Chondrotransplant DISC 77
93. 3.8.3.7 co.don Chondrosphere 77
94. 3.8.3.8 co.don Osteotransplant DENT 77
95. 3.8.3.9 MACI Implant 77
96. 3.8.3.10 Cartilink-3 77
97. 3.8.3.11 Accell Evo3 Demineralized Bone Matrix 78
98. 3.8.3.12 OsSatura BCP 78
99. 3.8.4 Mozobil 78
101. 4. Market Analysis of Regenerative Medicine Sector 79
102. 4.1 Scope of this Chapter 79
103. 4.1.1 Market for Regenerative Medicine Products 79
104. 4.1.2 The Different Characteristics of Regenerative Medicine Industry in the Recent Past 82
105. 4.1.3 Potential Market for Regenerative Medicine in the U.S 83
106. 4.2 Global Market for Stem Cells 84
107. 4.3 Market for Cell Therapy in the U.S. 85
108. 4.4 Global Market for Cord Blood Stem Cells 85
109. 4.4.1 Public Cord Blood Banks 86
110. 4.4.2 Private Cord Blood Banks 86
112. 5. Business Models and Requirements for a Successful Regenerative Medicine Industry 88
113. 5.1 Scope of this Chapter 88
114. 5.1.1 The Limited Success Achieved by the Regenerative Medicine Products 88
115. 5.1.2 Business Models in Regenerative Medicine 88
116. 5.1.3 Current Model for Autologous Cell Therapies 90
117. 5.1.4 Current Models for Allogeneic Cell Therapies 91
118. 5.1.5 Key Factors for Successful Business Models for Cell Therapies 92
119. 5.2 Commercial Manufacturing of Cell Therapy Products: Requirements 93
120. 5.2.1 Elements of Commercial Manufacturing 93
121. 5.2.1.1 Regulatory Requirements 93
122. 5.2.1.2 Manufacturing Process Scale 93
123. 5.2.1.3 In-House Manufacturing 94
124. 5.2.1.4 Contract Manufacturing: Commercial and Academic 94
126. 6. Diseases with Potential Applications for Regenerative Medicine 97
127. 6.1 Regenerative Medicine and Diabetes 99
128. 6.2 Regenerative Medicine for Cardiac Repair 100
129. 6.3 Regenerative Medicine in Orthopedics 100
130. 6.3.1 Orthobiologics in Orthopedics 100
131. 6.3.2 Growth Factor Therapies in Orthopedics 101
132. 6.3.3 Stem Cell Therapies in Orthopedics 101
133. 6.4 Regenerative Medicine in Liver Diseases 101
134. 6.4.1 Hepatocyte-like Cells for Liver Disease 102
135. 6.4.2 Cell Therapy for Liver Cirrhosis 102
136. 6.4.3 CD 34+ Cells 102
137. 6.5 Regenerative Medicine in Retinal Replacement Therapy 102
138. 6.5.1 Retinal Transplantation 102
139. 6.6 Regenerative Medicine in Central Nervous System (CNS) Disorders 103
140. 6.6.1 Clinical Activity for Stem Cell Transplantation into the CNS 103
142. 7. Current Stem Cell Research and Federal Funding in the U.S. 104
143. 7.1 Scope of this Chapter 104
144. 7.2 Stem Cell Policies in North America 104
145. 7.3 Stem Cell Policies in South America 105
146. 7.4 Stem Cell Policies in Europe 105
147. 7.5 Stem Cell Policies in Asia/Oceania 107
148. 7.6 Stem Cell Policies in Africa 108
149. 7.7 Stem Cell Research and California Institute for Regenerative Medicine (CIRM) 108
150. 7.7.1 CIRM Collaborative Funding 109
151. 7.7.2 CIRM's funding for Clinical Applications 110
152. 7.7.3 Early Translational Awards 110
153. 7.7.4 CIRM's Disease Team Awards 111
154. 7.8 Stem Cell Research Programs in Connecticut Department of Public Health 111
155. 7.8.1 Seed Grant Awards from Connecticut Stem Cell Research Program in 2010 111
156. 7.8.2 Established Investigator Awards from Connecticut Stem Cell Research Program in 2010 111
157. 7.8.3 Group Project Awards from Connecticut Stem Cell Research Program in 2010 112
158. 7.8.4 Core Facility Awards from Connecticut Stem Cell Research Program in 2010 113
159. 7.8.5 Maryland Technology Development Corporation (TEDCO) 113
160. 7.8.6 TEDCO's Fort Detrick Technology Transfer Initiative (FDTTI) 113
161. 7.8.7 J&J Investment Fund 113
162. 7.8.8 TEDCO's NAVAIR Technology Insertion (NAVTI) Program 113
163. 7.8.9 TEDCO's TechStart Program 113
164. 7.8.10 TEDCO's University Technology Development Fund (UTDF) 113
165. 7.8.11 TEDCO's Working Capital Loan Fund 113
166. 7.8.12 Maryland Technology Transfer and Commercialization Fund (MTTCF) 113
167. 7.8.13 Maryland Stem Cell Research Fund 114
168. 7.9 The New Jersey Commission on Science and Technology (NJCST) 114
169. 7.9.1 Investigator Initiated Research Projects and Innovative (IIRP), Developmental or Exploratory Activities (IDEA) in Stem Cell Research 115
170. 7.9.2 Targeted RFA for Investigation of iPS and Other Derivation Approaches 116
171. 7.9.3 Shared Facilities/Resources and Equipment/Instrumentation for Stem Cell Research 116
172. 7.9.4 Consortia Planning Awards 116
173. 7.9.5 Institutional Development 116
174. 7.10 Center for Stem Cell and Regenerative Medicine 116
175. 7.11 Global Funding for Regenerative Medicine 117
176. 7.12 Federal Funding of Stem Cell Research in the U.S.: Past and Present 117
177. 7.12.1 The U.S. National Institute of Health (NIH) Guidelines to hESC Research 118
178. 7.12.2 Types of Research Ineligible for NIH Funding 118
179. 7.12.3 NIH's Leadership in Providing Funds for Stem Cell Research 118
180. 7.12.4 NIH Guidelines Addressing the Projected Growth of Stem Cell-related Clinical Trials 118
181. 7.12.5 Federal Agencies Providing Funds for Stem Cell Research 118
183. 8. Company Profiles 120
184. 8.1 Aastrom Biosciences, Inc. 120
185. 8.1.1 Aastrom's Clinical Trial Programs 120
186. 8.1.1.1 Dilated Cardiomyopathy 120
187. 8.1.1.2 Critical Limb Ischemia 120
188. 8.1.1.3 Osteonecrosis of the Femoral Head 120
189. 8.1.1.4 Other Bone Disorders 120
190. 8.1.2 Product Development 121
191. 8.1.3 Aastrom's Cell Manufacturing 121
192. 8.1.4 Aastrom's Business Performance 121
193. 8.2 Advanced Cell Technology, Inc. (ACT) 122
194. 8.2.1 ACT's Cellular Reprogramming 122
195. 8.2.2 ACT's Stem Cell Differentiation 123
196. 8.2.2.1 ACT's Retinal Pigment Epithelium Program 123
197. 8.2.2.2 ACT's Hemangioblast Program 123
198. 8.2.2.3 ACT's Adult Stem Cell Program 123
199. 8.2.3 ACT's Intellectual Property 123
200. 8.2.4 ACT's Business Performance 124
201. 8.2.5 ACT's Investment in Research and Development 125
202. 8.3 Aldagen, Inc. 125
203. 8.3.1 Aldagen's ALD-201 126
204. 8.3.2 Aldagen's ALD-301 126
205. 8.4 Altrika Ltd. 126
206. 8.4.1 Myskin 126
207. 8.4.2 Cryoskin 127
208. 8.4.3 Altrika's Future Products 127
209. 8.4.3.1 Lyphoderm 127
210. 8.4.3.2 Corneal Bandage 127
211. 8.4.3.3 Leukodepletion Filters 128
212. 8.5 Alseres Pharmaceuticals, Inc. 128
213. 8.5.1 Alseres' Product Pipeline 128
214. 8.5.1.1 Celthrin-a Rho Inhibitor 129
215. 8.5.1.2 Inosine 129
216. 8.5.1.3 Oncomodulin and ALSE-100 130
217. 8.5.1.4 Altropane-PD 130
218. 8.5.2 Alseres' Science and Technology 131
219. 8.5.2.1 Nerve Repair Pathways 131
220. 8.5.2.2 The Pro-Regenerative Pathway 132
221. 8.5.2.3 The Anti-Regenerative Pathway 132
222. 8.5.2.4 Molecular Imaging 132
223. 8.5.2.5 Dopamine Transporter 133
224. 8.6 Amgen, Inc. 134
225. 8.6.1 Amgen's Marketed Products 135
226. 8.6.1.1 Aranesp (Darbepoetin Alfa) 135
227. 8.6.1.2 Epogen (Epoetin Alfa) 136
228. 8.6.1.3 Neulasta (Pegfilgrastim)/Neupogen (Filgrastim) 136
229. 8.6.1.4 Enbrel (Etanercept) 137
230. 8.6.1.5 Sensipar (cinacalcet) 138
231. 8.6.1.6 Vectibix (Panitumumab) 138
232. 8.6.1.7 Nplate (Romiplostim) 139
233. 8.6.2 Amgen's Marketing and Distribution 139
234. 8.6.3 Amgen's Overall Business Performance 140
235. 8.7 Amorcyte, Inc. 141
236. 8.7.1 Amorcyte's Technology 141
237. 8.7.1.1 AMR-001 141
238. 8.8 AnGes MG, Inc. 142
239. 8.8.1 AnGes' Genetic Medicine 142
240. 8.8.2 HGF Genetic Medicine 142
241. 8.8.3 Hemagglutinating Virus of Japan (HVJ) Envelope Vector 143
242. 8.8.4 NF kB Decoy Oligodeoxynucleotide 143
243. 8.9 Angioblast Systems, Inc. 145
244. 8.9.1 Angioblast's Technology and Applications 145
245. 8.9.1.1 Allogenic Adult Stem Cells 145
246. 8.9.1.2 Protein Therapeutics 145
247. 8.9.1.3 Gene Slicing 145
248. 8.10 Angion Biomedica, Corp. 146
249. 8.10.1 HGF and c-Met Signaling in Tissue Repair and Organ Regeneration 147
250. 8.10.2 PARP-1 147
251. 8.10.3 TGF B1 148
252. 8.11 Ars Arthro Biotechnology, Inc. 148
253. 8.11.1 CaReS 148
254. 8.11.2 Fibrocell 148
255. 8.11.3 Fibroplus 149
256. 8.12 Arteriocyte Medical Systems, Inc. 149
257. 8.12.1 Blood Pharming 149
258. 8.12.2 Cardiac Ischemia 149
259. 8.12.3 Critical Limb Ischemia 149
260. 8.12.4 Malaria Research 150
261. 8.12.5 Orthopedic Regenerative Medicine 150
262. 8.12.6 Proliferative Diabetic Retinopathy 150
263. 8.12.7 Wound Healing 150
264. 8.13 Athersys, Inc. 151
265. 8.13.1 Athersys' Pipeline 151
266. 8.13.2 MultiStem for Stem Cell Therapy 151
267. 8.13.3 MultiStem for BM Transport Support 152
268. 8.13.4 MultiStem for Acute Myocardial Infarction 152
269. 8.13.5 MeriStem for Stroke 152
270. 8.13.6 Treatments for Obesity 153
271. 8.13.7 Histamine H3 Receptor Antagonists 153
272. 8.13.8 Athersys' Collaborations and Partnerships 153
273. 8.13.8.1 Collaboration with Pfizer 153
274. 8.13.8.2 Collaboration with Angiotech 153
275. 8.13.8.3 Collaboration with Bristol-Myers Squibb 153
276. 8.13.9 Athersys' Research and Development 153
277. 8.13.10 Athersys' Business Performance 154
278. 8.14 BeFutur Biotechnologies 154
279. 8.14.1 BeFutur's Technologies 155
280. 8.14.1.1 Cells and Tissue Engineering 155
281. 8.14.1.2 Serum Free Technology 155
282. 8.15 BioE, Inc. 155
283. 8.15.1 BioE's Products 155
284. 8.16 Bioheart, Inc. 155
285. 8.16.1 Bioheart's Product Candidates 156
286. 8.16.1.1 MyoCell 156
287. 8.16.1.2 MyoCell SDF-1 156
288. 8.16.1.3 TGI 1200 Cell Isolation System 156
289. 8.16.1.4 Bioheart 3370 156
290. 8.16.2 Bioheart's Patents and Proprietary Rights 157
291. 8.17 BioLine Rx 157
292. 8.17.1 BioLine's Product Pipeline 157
293. 8.17.1.1 BL-1020 Schizophrenia 157
294. 8.17.1.2 BL-1040 for Acute Myocardial Infarction 157
295. 8.17.1.3 BL-5010 for Skin Lesions 158
296. 8.17.1.4 BL-1021 for Neuropathic Pain 158
297. 8.17.1.5 BL-2030 for Inflammation 158
298. 8.17.1.6 BL-1023 for Parkinson's disease 158
299. 8.17.1.7 BL-4010 for Cancer 158
300. 8.17.1.8 BL-4040 for Acute Kidney Failure 158
301. 8.17.1.9 BL-5030 for Thromboembolic Diseases 158
302. 8.17.1.10 BL-5040 for Cachexia and Inflammatory Bowel Disease 159
303. 8.18 BIOMET 159
304. 8.18.1 BIOMET 3i 159
305. 8.18.2 Clotalyst Autologous Serum Collection System 159
306. 8.18.3 BioCUE Platelet Concentration System 159
307. 8.19 BioMimetic Therapeutics, Inc. 160
308. 8.19.1 BioMimetic's Product Candidates 160
309. 8.19.2 BioMimetic's Research and Development 161
310. 8.20 BioSafe Group SA 161
311. 8.20.1 Sepax 162
312. 8.20.2 Sepax System in Adult Stem Cell Banking 162
313. 8.20.3 Coolmix 162
314. 8.20.4 SepaxNet 163
315. 8.21 BioTime, Inc. 163
316. 8.21.1 BioTime's Stem Cell Products for Regenerative Medicine 164
317. 8.21.2 BioTime's Embryome Database 164
318. 8.21.3 BioTime's Progenitor and hES Cell Lines 164
319. 8.21.4 BioTime's hES Cells Carrying Genetic Diseases 164
320. 8.21.5 BioTime's ESpan Cell Growth Media 164
321. 8.21.6 BioTime's ESpy Cell Lines 164
322. 8.21.7 BioTime's Licensed Stem Cell Technology and Stem Cell Product Development Agreements 165
323. 8.21.7.1 Wisconsin Alumni Research Foundation 165
324. 8.21.7.2 ACTCellerate Technology 165
325. 8.21.7.3 The iPS Technology 165
326. 8.21.7.4 Lifeline 165
327. 8.21.7.5 BioTime's Stem Cell Agreement with Reproductive Genetics Institute 165
328. 8.21.8 BioTime's Plasma Volume Expanders and Related Products 165
329. 8.21.8.1 Hextend 165
330. 8.21.8.2 PentaLyte 166
331. 8.22 Biovest International, Inc. 166
332. 8.22.1 BiovaxID Cancer Vaccine 166
333. 8.23 BrainStorm Cell Therapeutics, Inc. 166
334. 8.23.1 BrainStorm's Technology 166
335. 8.23.2 BrainStorm's Stem Cell Therapy 167
336. 8.23.3 BrainStorm Technology-NurOwn 167
337. 8.24 Cardio3 BioSciences 168
338. 8.24.1 Cardio3's Product Pipeline 168
339. 8.24.1.1 C-Cure 169
340. 8.24.1.2 C-Cure2 169
341. 8.24.1.3 Allo-Cure 169
342. 8.24.1.4 G-Cure 169
343. 8.24.1.5 C-Cath 169
344. 8.24.2 Cardio3's Investors 169
345. 8.25 CardioPolymers, Inc. 170
346. 8.25.1 CardioPolymer's Products 170
347. 8.25.1.1 Algisyl-LVR 170
348. 8.25.1.2 Plexisyl-AF 171
349. 8.25.2 CardioPolymer's Investors 171
350. 8.26 CaridianBCT 171
351. 8.26.1 Trima Accel Automated Blood Collection System 171
352. 8.26.2 Spectra Optia Apheresis System 172
353. 8.26.3 COBE Spectra Apheresis System 172
354. 8.26.4 Elutra Cell Separation System 172
355. 8.26.5 Atreus Whole Blood Processing System 173
356. 8.26.6 OrbiSac System 173
357. 8.26.7 COBE 2991 Cell Processor 173
358. 8.27 Cardium Therapeutics, Inc. 174
359. 8.27.1 Cardium Biologics 174
360. 8.27.2 Cardium's Tissue Repair Company 174
361. 8.27.3 Cardium's Gene Activated Matrix (GAM) Technology 175
362. 8.27.4 Cardium's Biologics and Stem Cells for Regenerative Medicine 175
363. 8.28 Cellartis AB 175
364. 8.28.1 Cellartis' Products 175
365. 8.28.1.1 The hES-CMC 2D: Cardiomyocyte Monolayers 175
366. 8.28.1.2 The hES-CMC 002: Cardiomyocyte Clusters 176
367. 8.28.1.3 The hES-HEO 002: Hepatocyte-like Cells 176
368. 8.28.1.4 The hES-MP 002.5: Mesenchymal Progenitors 177
369. 8.28.1.5 The hES Cell Lines 177
370. 8.28.1.6 SCED 461: Human ES Cells 177
371. 8.28.1.7 Monoclonal Antibodies 178
372. 8.28.2 Cellartis' Licensing Activities 178
373. 8.29 Cellerix 178
374. 8.29.1 Ontaril 179
375. 8.29.2 Cx501 179
376. 8.30 Celgene Corporation 180
377. 8.30.1 Celgene's Business Performance 180
378. 8.30.2 Celgene's Commercial Stage Products 181
379. 8.30.2.1 Revlimid (Lenalidomide) 181
380. 8.30.2.2 Thalomid (Thalidomide) 181
381. 8.30.2.3 Vidaza (Azacitidine for Injection) 182
382. 8.30.2.4 Ritalin Family of Drugs 182
383. 8.30.2.5 Alkeran (Melphalan) 182
384. 8.30.2.6 IMiDs Compounds 182
385. 8.30.2.7 Oral Anti-Inflammatory Agents 182
386. 8.30.2.8 Kinase Inhibitors 182
387. 8.30.2.9 Cellular Therapies 183
388. 8.31 CellSeed, Inc. 183
389. 8.31.1 CellSeed's Epithelial Cell Sheet for Corneal Regeneration 183
390. 8.31.2 CellSeed's Regenerated Cardiac Patch 184
391. 8.31.3 CellSeed's Epithelial Cell Sheet for Esophageal Regeneration 184
392. 8.31.4 CellSeed's Cell Sheet for Periodontal Tissue Regeneration 184
393. 8.31.5 CellSeed's Regenerated Cartilage Sheet 184
394. 8.32 Cellular Dynamics International 184
395. 8.32.1 The iCell Cardiomyocytes 185
396. 8.32.2 Cellular Dynamics' Technology 185
397. 8.33 Celltrix 185
398. 8.33.1 Credurance 186
399. 8.34 Cerco Medical 186
400. 8.34.1 Cerco Medical's Concept 186
401. 8.34.2 Bio-artificial Endocrine Pancreas 187
402. 8.35 Cook Biotech, Inc. 187
403. 8.35.1 Cook's Technology 187
404. 8.35.2 Biodesign Dural Graft 188
405. 8.35.3 Dynamatrix Oral Graft 188
406. 8.35.4 SiS Ophthalmic 188
407. 8.35.5 Oasis Wound Matrix 188
408. 8.35.6 Biodesign Staple Line Reinforcement 188
409. 8.35.7 Biodesign Hiatal Hernia Graft 189
410. 8.35.8 ECM for Pericardial Closure 189
411. 8.35.9 ECM for Cardiac Tissue Repair 189
412. 8.35.10 Biodesign 8-Layer Tissue Graft 189
413. 8.35.11 Biodesign Abdominal Lock Graft 189
414. 8.35.12 Biodesign Hernia Graft 190
415. 8.35.13 Biodesign Inguinal Hernia Graft 190
416. 8.35.14 Biodesign Umbilical Hernia Graft 190
417. 8.35.15 Biodesign Anterior Pelvic Floor Graft 191
418. 8.35.16 Biodesign Fistula Plug 191
419. 8.35.17 Biodesign Posterior Pelvic Floor Graft 191
420. 8.35.18 Surgisis Biodesign Peyronie's Repair Graft 192
421. 8.35.19 Biodesign Tension-free Urethral Sling 192
422. 8.35.20 Biodesign Vaginal Erosion Repair Graft 192
423. 8.35.21 AxoGuard Nerve Protector 193
424. 8.35.22 AxoGuard Nerve Connector 193
425. 8.35.23 FISH Femoral Introducer Sheath and Hemostasis Device 193
426. 8.36 Cord Blood America (CBAI), Inc. 193
427. 8.37 Cryo-Cell International, Inc. 193
428. 8.37.1 Cryo Cell's License Agreements 193
429. 8.37.1.l Cryo-Cell De Mexico 193
430. 8.37.1.2 Asia Cryo-Cell Private Limited 194
431. 8.37.1.3 Venezuela 194
432. 8.37.1.4 China 194
433. 8.37.1.5 Germany 194
434. 8.37.1.6 Nicaragua 194
435. 8.37.1.7 Pakistan 194
436. 8.37.2 Uses of Cord Blood Stem Cells 195
437. 8.38 Curis, Inc. 197
438. 8.38.1 Curis' Business Performance 198
439. 8.38.2 Curis' Research and Development 198
440. 8.39 Cytori Therapeutics, Inc. 199
441. 8.39.1 Cytori's Cosmetic and Reconstructive Surgery Market 200
442. 8.39.2 Cytori StenSource Cell Banking Market 200
443. 8.40 Develogen AG 201
444. 8.40.1 Develogen's Pipeline 201
445. 8.40.1.1 DG3173-Somatostatin Analog 201
446. 8.40.1.2 Insulin Sensitizers 201
447. 8.40.1.3 Beta Cell Regeneration Factor 201
448. 8.41 Effector Cell Institute, Inc (ECI) 202
449. 8.41.1 ECI's Cell-based Drug Discovery (CDD) 202
450. 8.41.2 ECI's Regenerative Medicine 202
451. 8.41.3 ECI's Cancer Therapeutic Agent Development Project (EC1301) 202
452. 8.41.4 ECI's Anti-Inflammatory Drug Development Project (FROUNT) 203
453. 8.41.5 ECI's High Throughput Screening by Automatic TAXIScan System 203
454. 8.41.6 ECI's Products 204
455. 8.41.6.1 TAXIScan System 204
456. 8.41.6.2 Cytorecon 204
457. 8.41.6.3 TAXIScan-FL 204
458. 8.42 Epistem plc 205
459. 8.42.1 Epistem's Cotract Research Services in Oncology 205
460. 8.42.2 Epistem's Xenografting Models 205
461. 8.42.3 Epistem's Cancer Cell Assays 205
462. 8.42.4 Epistem's Angiogenesis Models 206
463. 8.42.5 Epistem's Colon Cancer Models (Min/+) 206
464. 8.42.6 Epistem's Histology, IHC, ISH and Gene Expression Profiling 206
465. 8.42.7 Epistem's In vitro Cytotoxicity Testing 206
466. 8.42.8 Epistem's Plucked Hair Immunohistochemistry 207
467. 8.42.9 Epistem's Emerging Protein Therapeutics 207
468. 8.42.10 Epistem's Biomarker Technology 207
469. 8.43 FivePrime Therapeutics, Inc. 208
470. 8.43.1 FivePrime's Technology 208
471. 8.43.2 FivePrime's Collaborations 209
472. 8.44 Forticell Bioscience, Inc. 209
473. 8.44.1 OrCell 210
474. 8.45 Gamidia Cell Ltd. 210
475. 8.45.1 Gamidia's Technology 210
476. 8.46 GeneGrafts Ltd. 211
477. 8.46.1 Gene Graft's Technology 211
478. 8.47 GenVec, Inc. 211
479. 8.47.1 GenVec's Product Programs 212
480. 8.47.1.1 TNFerade 212
481. 8.47.1.2 Hearing and Balance 212
482. 8.48 Genzyme Corporation 212
483. 8.48.1 Genzyme's Business Performance 212
484. 8.48.2 Genzyme's Genetic Diseases Segment 213
485. 8.48.3 Genzyme's Hematology Oncology Segment 214
486. 8.48.4 Genzyme's Cardiometabolic and Renal Segment 215
487. 8.48.5 Genzyme's Biosurgery Segment 215
488. 8.48.6 Genzyme's Genetics and Diagnostics Segment 216
489. 8.48.7 Genzyme's Pipeline 216
490. 8.49 Geron Corporation 218
491. 8.49.1 Geron's Major Technology Platforms 218
492. 8.49.1.1 Role of Telomere in Cancer and Aging 218
493. 8.49.1.2 Human Embryonic Stem Cells: Source for the Manufacturing of Therapeutic Cells 218
494. 8.49.2 Commercial Opportunities for Geron's Major Technology Platforms 218
495. 8.49.2.1 Oncology 218
496. 8.49.3 Geron's Human Embryonic Stem Cell Therapies 219
497. 8.49.4 Geron's Patents and Proprietary Technology 219
498. 8.49.5 Geron's Business Performance 220
499. 8.49.6 Geron's Investment in Research and Development 221
500. 8.50 Harvest Technologies Corporation 221
501. 8.50.1 Harvest Technologies' Products 221
502. 8.50.1.1 SmartPReP2 APC+ 221
503. 8.50.1.2 SmartPReP 2 BMAC 222
504. 8.51 HemaStem Therapeutics, Inc. 222
505. 8.51.1 Cord Blood Program 222
506. 8.52 HepaLife Technologies, Inc. 223
507. 8.52.1 Liver Disease 223
508. 8.52.1.1 HepaMate 223
509. 8.53 Humacyte, Inc. 224
510. 8.53.1 Humacyte's Products 224
511. 8.54 Hydra Biosciences, Inc. 224
512. 8.54.1 Hydra's Program 224
513. 8.55 Intercytex Group plc 225
514. 8.55.1 Vavelta-Skin Repair and Rejuvenation 225
515. 8.55.2 SHEF-1-Stem Cell Line 226
516. 8.55.3 CX-SKN-Skin Graft Replacement for Burns and Acute Wounds 226
517. 8.55.4 ICX-TRC-Hair Regeneration 227
518. 8.55.5 Cyzact-Chronic Wound Repair 227
519. 8.56 Integra Lifesciences Holdings Corporation 227
520. 8.56.1 Integra's Products 228
521. 8.56.1.1 Integra's Orthopedic Product Portfolio 228
522. 8.56.1.2 Dermal Regeneration and Engineered Wound Dressings 228
523. 8.56.1.3 Nerve and Tendon 228
524. 8.56.1.4 Bone Graft Substitutes for Extremity Reconstruction 228
525. 8.56.1.5 Integra's OrthoBiologics 229
526. 8.56.1.6 Duraplasty Products 229
527. 8.56.2 Integra's Investment in Research and Development 229
528. 8.56.3 Integra's Business Performance 230
529. 8.57 International Stem Cell Corporation (ISCO) 230
530. 8.57.1 Lifeline Cell Technology 230
531. 8.57.2 Universal Stem Cell Bank 231
532. 8.57.3 ISCO's Technology 231
533. 8.58 Japan Tissue Engineering, Co., Ltd. 231
534. 8.58.1 Autologous Cultured Epidermis 232
535. 8.58.2 Autologous Cultured Cartilage 232
536. 8.58.3 Autologous Cultured Corneal Epithelium 233
537. 8.59 Karocell Tissue Engineering AB 234
538. 8.59.1 Karocell's Autologous Cells 234
539. 8.59.1.1 Keratinocytes 234
540. 8.59.1.2 Melanocytes 234
541. 8.59.1.3 Fibroblasts 234
542. 8.59.1.4 Chondrocytes 234
543. 8.59.1.5 Urothelial Cells 234
544. 8.59.1.6 Karoskin 235
545. 8.59.1.7 Karoderm 235
546. 8.59.1.8 Cell Bank 235
547. 8.59.2 Karocell's Research and Development 235
548. 8.60 Kensey Nash Corporation 235
549. 8.60.1 Biomaterials from Kensey 236
550. 8.60.2 Kensey's Collagen Technology 236
551. 8.60.3 Porous Tissue Matrix Technology 237
552. 8.60.4 Kensey's Products 237
553. 8.60.4.1 The Angio-Seal Vascular Closure Device 237
554. 8.60.4.2 Vitoss Scaffold Foam 238
555. 8.60.4.3 OsseoFit Porous Tissue Matrix 238
556. 8.60.4.4 Epi-Guide Bioresorbable Barrier Matrix 238
557. 8.61 Kiadis Pharma, BV 238
558. 8.62 LifeCell 239
559. 8.62.1 AlloDerm Regenerative Tissue Matrix 239
560. 8.62.2 Strattice Reconstructive Tissue Matrix 239
561. 8.62.3 Cymetra Micronized AlloDerm Tissue 239
562. 8.63 MaxCyte, Inc. 239
563. 8.63.1 Advantages of MaxCyte Platform System 240
564. 8.63.2 MaxCyte's Collaborations 240
565. 8.63.3 MaxCyte's Application in Immunotherapy 240
566. 8.63.4 MaxCyte's Application in Regenerative Medicine 241
567. 8.63.5 MaxCyte's Viral Vectors and Vaccines 241
568. 8.63.6 MaxCyte XTS Scalable Transfection System 241
569. 8.64 Mesoblast Ltd. 241
570. 8.64.1 Mesoblast's Intervertebral Spinal Fusion 242
571. 8.64.2 Lumbar Fusion 242
572. 8.64.3 Cervical Fusion 242
573. 8.64.4 Mesoblast's Intervertebral Disc Repair and Regeneration 242
574. 8.64.5 Mesoblast's Product for Knee Osteoarthritis 242
575. 8.64.6 Mesoblast's Investment in Angioblast Systems, Inc. 242
576. 8.64.7 Angioblast's Product Candidate for Congestive Heart Failure 243
577. 8.64.8 Angioblast's Product Candidate for Bone Marrow Transplantation 243
578. 8.65 NanoCor Therapeutics, Inc. 243
579. 8.65.1 NanoCor's Products 243
580. 8.66 NeuralStem, Inc. 243
581. 8.66.1 NeuralStem's Technology 244
582. 8.66.2 NeuralStem's Research and Programs 244
583. 8.66.3 NeuralStem's Intellectual Property 245
584. 8.67 NeuroNova AB 246
585. 8.67.1 NeroNova's Neurogenesis Qualifier-Technology 246
586. 8.67.2 The sNN0029 246
587. 8.67.3 The sNN0031 247
588. 8.67.4 NeuroNova's Investors 247
589. 8.68 Olympus Terumo Biomaterials Corporation 247
590. 8.68.1 OSferion 60 248
591. 8.68.2 Terudermis 248
592. 8.68.3 Teruplug 248
593. 8.68.4 Osferion 249
594. 8.68.5 Boneceram P 249
595. 8.69 Opexa Therapeutics, Inc. 249
596. 8.69.1 Opexa's T-Cell Platform 249
597. 8.69.2 Opexa's Stem Cell Platform 250
598. 8.70 Organogenesis, Inc. 250
599. 8.70.1 Products from Organogenesis 250
600. 8.70.1.1 Apligraf 250
601. 8.70.1.2 VCT01 250
602. 8.70.1.3 CelTx for Oral Soft Tissue Regeneration 251
603. 8.70.1.4 FortaGen 251
604. 8.70.1.5 FortaPerm 251
605. 8.70.1.6 BioSTAR 251
606. 8.71 Orthovita, Inc. 251
607. 8.71.1 Orthovita's Products 252
608. 8.71.1.1 Vitoss 252
609. 8.71.1.2 Vitoss and Bone Defect Grafting 252
610. 8.71.1.3 Vitoss in Spinal Fusion and Grafting 253
611. 8.71.1.4 Vitoss and Trauma 253
612. 8.71.1.5 Vitomatrix and Dental, Periodontal, Oral and Craniomaxillofacial Defects 253
613. 8.71.1.6 Cortoss Bone Augmentation Material 253
614. 8.71.1.7 Cortoss and Vertebral Augmentation of VCFs 253
615. 8.71.1.8 Cortoss and Screw Augmentation 253
616. 8.71.1.9 Orthovita's Aliquot Delivery System 254
617. 8.71.2 Orthovita's Biosurgery Products 254
618. 8.71.3 Partnership with Kensey for Vitoss Foam 254
619. 8.71.4 Partnership with Angiotech for Vitagel and CellPaker 254
620. 8.71.5 Partnership with Medafor for Vitasure 255
621. 8.71.6 Orthovita's Business Performance 255
622. 8.72 Osiris Therapeutics, Inc. 255
623. 8.72.1 Osiris' Partnerships 256
624. 8.72.2 Osiris' Technologies 256
625. 8.72.3 Prochymal 256
626. 8.72.4 Chondrogen 257
627. 8.73 Osteotech, Inc. 257
628. 8.73.1 Osteotech's Products 257
629. 8.74 Pervasis Therapeutics, Inc. 258
630. 8.74.1 Pervasis' Clinical Focus 258
631. 8.74.2 Power of Endothellium 258
632. 8.74.3 Therapeutic Applications of Pervasis' Products 259
633. 8.74.3.1 Arteriovenous (AV) Access for Hemodialysis 259
634. 8.74.3.2 Peripheral Arterial Disease 259
635. 8.75 Pleuron 260
636. 8.75.1 Pleuron's Technology 260
637. 8.76 Pluristem Therapeutics, Inc. 260
638. 8.76.1 Pluristem's PluriX 3D Bioreactor 260
639. 8.76.2 Pluristem's PLacental eXpanded (PLX) Cells 260
640. 8.76.3 PLX-PAD for Peripheral Artery Disease 260
641. 8.76.4 PLX-IBD for Inflammatory Bowel Disease 261
642. 8.76.5 PLX-MS for Multiple Sclerosis 261
643. 8.76.6 PLX-STROKE for Ischemic Stroke 261
644. 8.77 RegeneRx 261
645. 8.78 ReNeuron Group plc 261
646. 8.78.1 ReNeuron's Platform Technologies 262
647. 8.78.2 ReNeuron's Cell Therapy Programs 263
648. 8.78.3 ReNeuron's ReN001 for Stroke 263
649. 8.78.4 ReNeuron's ReNcell Products 264
650. 8.79 Revivicor, Inc. 264
651. 8.79.1 Revivicor's Xenografting Technology 264
652. 8.79.2 Revivicor's Islet Transplantation Technology 264
653. 8.79.3 Revivicor's Infectious Disease Platform Technologies 265
654. 8.80 Saneron CCEL Therapeutics, Inc. 265
655. 8.80.1 Saneron's U-Cord-Cell Program 265
656. 8.80.2 Saneron's Sert-Cell Program 265
657. 8.81 Sangamo BioSciences, Inc. 265
658. 8.81.1 Sangamo's ZFP Therapeutic Product Development Programs 266
659. 8.81.2 ZFP Therapeutic Pre-clinical Stage Programs 266
660. 8.81.2.1 Neuropathic Pain (Cancer Pain) 266
661. 8.81.2.2 Nerve Regeneration-Spinal Cord Injury (SCI) and Traumatic Brain Injury (TBI) 266
662. 8.81.2.3 Parkinson's Disease (PD) 267
663. 8.81.2.4 Stroke 267
664. 8.81.2.5 ZFP Therapeutic Research Programs 267
665. 8.81.3 Funding from Research Foundations 267
666. 8.81.3.1 The Juvenile Diabetes Research Foundation International 267
667. 8.81.3.2 The Michael J. Fox Foundation 267
668. 8.81.3.3 The Bill and Melinda Gates Foundation 267
669. 8.81.4 Sangamo's Research and Development Expenses 267
670. 8.81.5 Sangamo's Business Performance 268
671. 8.82 StemCells, Inc. 268
672. 8.82.1 StemCell's Cellular Medicine Programs 269
673. 8.82.2 StemCells' Enabling Technologies Program 270
674. 8.82.3 StemCells' Patents, Proprietary Rights and Licenses 270
675. 8.83 Stem Cell Authority Ltd. 271
676. 8.83.1 The "Miracle" Mesenchymal Stem Cell-Mirachymal Stem Cells 272
677. 8.84 Stem Cell Innovations (SCI) 272
678. 8.84.1 SCI's Research and Development 272
679. 8.84.2 SCI's Services 272
680. 8.84.3 PluriCells and Derivatives 272
681. 8.84.4 ACTIVTox 273
682. 8.84.5 PredictivTox 273
683. 8.84.6 Endogenous Protein Production 273
684. 8.85 Stem Cell Sciences KK 273
685. 8.85.1 SCS KK's Product/Service 273
686. 8.85.1.1 CultiCell Medium for Embryonic Stem Cells 273
687. 8.85.1.2 Contract/Sponsored Research on ES-derived Functional Cells 274
688. 8.86 SyntheMed, Inc. 274
689. 8.86.1 Repel-CVAdhesion Barrier 274
690. 8.86.2 Resolve Adhesion Barrier Instillate 274
691. 8.86.3 Repel Adhesion Barrier 275
692. 8.86.4 SpineShield Adhesion Barrier Film 275
693. 8.86.5 Relieve Adhesion Barrier Gel 275
694. 8.86.6 SinusShield Adhesion Prevention Film 275
695. 8.87 t2cure GmbH 275
696. 8.87.1 BMCs in Regenerative Therapies 275
697. 8.87.2 t2cure's Product Development Pipeline 275
698. 8.88 Tengion 276
699. 8.88.1 Tengion's Pipeline Overview 276
700. 8.89 TiGenix 277
701. 8.89.1 ChondroCelect 277
702. 8.89.2 Chondromimetic 277
703. 8.89.3 TGX002 277
704. 8.89.4 TGX003 277
705. 8.90 Thermogenesis Corp. 278
706. 8.90.1 Products from Thermogenesis 278
707. 8.90.1.1 AutoXpress Platform or AXP 278
708. 8.90.1.2 MarrowXpress 278
709. 8.90.1.3 BioArchive System 278
710. 8.90.1.4 Res-Q 278
711. 8.90.1.5 Thermoline 278
712. 8.90.1.6 CryoSeal Fibrin Sealant (CryoSeal) System 278
713. 8.90.2 Thermogenesis' Business Performance 279
716. INDEX OF FIGURES
718. Figure 2.1: Geographic Distribution of 73 TERM Firms in the Five Focus Countries, 2009 29
719. Figure 2.2: Geographic Distribution of the 15 TERM Firms in Germany, 2009 30
720. Figure 2.3: Geographic Distribution of the Five TERM Companies in the U.K., 2009 30
721. Figure 2.4: The Potential Uses of Embryonic Stem Cells 32
722. Figure 2.5: Cell Culture Products by Market Segment 34
723. Figure 2.6: Estimated Global Market for Cell and Tissue Analysis Products, 2008-2014 35
724. Figure 2.7: Growth in Size of Cell Therapy Industry, 2000-2008 40
725. Figure 2.8: Percent Break-up of Cell Therapy Companies by Product Type, 2008 41
726. Figure 2.9: Location of Primary Tissue Engineering Companies by Geography, 2008-2009 42
727. Figure 2.10: Breakdown of Primary Cell Therapy Products on Market by Geography, 2008-2009 44
728. Figure 2.11: The Geographical Distribution of Clinical Trials, 2008-2009 47
729. Figure 2.12: Implantation of a Hydrogel at the Site of an Injured Tissue 57
730. Figure 2.13: Implantation of CS-PEG Hydrogel 57
731. Figure 2.14: Implantation of CMP-PEG Scaffold 58
732. Figure 4.1: Global Market for Regenerative Medicine Products, 2008-2013 79
733. Figure 4.2: Estimated market for Regenerative Cell Therapy Products for Orthopedics, 2008-2012 80
734. Figure 4.3: Estimated U.S. Market for Regenerative Medicine Products, 2009-2014 80
735. Figure 4.4: Estimated U.S. Market for Bone Grafting/Bone Replacement, 2009-2014 81
736. Figure 4.5: Estimated U.S. Market for Bone Growth Stimulating Substances, 2009-2014 81
737. Figure 4.6: Estimated U.S. Market for Regenerative Products for Cartilage Repair, 2009-2014 82
738. Figure 4.7: Estimated Market for Stem cells, 2008-2012 84
739. Figure 4.8: Estimated Market for Cell Therapy Products in the U.S., 2009-2018 85
740. Figure 4.9: Estimated Global Market for Cord Blood Stem Cells, 2010-2015 86
741. Figure 4.10: Worldwide Growth of Public Cord Blood Banks, 2005-2009 86
742. Figure 4.11: Worldwide Growth of Private Cord Blood Banks, 2005-2009 87
743. Figure 5.1: Cell-based Business Models 89
744. Figure 5.2: Current Autologous Business Models 91
745. Figure 5.3: Current Allogeneic Business Models 92
746. Figure 7.1: CIRM's Grant Awards by Category, 2009 109
747. Figure 7.2: CIRM's Funding by Disease Application, 2009 110
748. Figure 7.3: CIRM's Funding by Disease Category 111
749. Figure 7.4: Estimated Increase in Worldwide Funding for RM Research, 2008-2018 117
750. Figure 8.1: Aastrom's Investment in Research and Development, 2007-2009 121
751. Figure 8.2: Aastrom's Business Performance, 2005-2009 122
752. Figure 8.3: ACT's Business Performance, 2008 and 2009 125
753. Figure 8.4: ACT's Investment in Research and Development, 2008 and 2009 125
754. Figure 8.5: Aranesp (Darbepoetin Alfa)'s Sales in the U.S. and International Market, 2007-2009 136
755. Figure 8.6: U.S. Market for Epogen, 2007-2009 136
756. Figure 8.7: Global Market for Neulasta, 2007-2009 137
757. Figure 8.8: Global Market for Enbrel (Etanercept), 2007-2009 137
758. Figure 8.9: Global Market for Sensipar (Cinacalcet), 2007-2009 138
759. Figure 8.10: Global Market for Vectibix (Panitumumab), 2007-2009 139
760. Figure 8.11: Global Market for Nplate (Romiplostim), 2007-2009 139
761. Figure 8.12: Amgen's Three Large Wholesale Customers, 2007-2009 140
762. Figure 8.13: Amgen's Overall U.S. and International Market, 2007-2008 140
763. Figure 8.14: Athersys' Investment and Development, 2007-2009 154
764. Figure 8.15: Athersys' Business Performance, 2005-2009 154
765. Figure 8.16: Current Capitalization of Cardio3's Investors, 2009 170
766. Figure 8.17: Celgene's Business Performance, 2005-2009 181
767. Figure 8.18: Curis' Business Performance, 2005-2009 198
768. Figure 8.19: Genzyme's Business Performance, 2005-2009 213
769. Figure 8.20: Genzyme's Percent of Revenue by Business Group, 2009 213
770. Figure 8.21: Geron's Business Performance, 2005-2009 220
771. Figure 8.22: Geron's Investment in Research and Development, 2005-2009 221
772. Figure 8.23: Integra's Investment in Research and Development, 2007-2009 229
773. Figure 8.24: Integra's Business Performance, 2005-2009 230
774. Figure 8.25: NeuroNova's Share Holders as of June, 2009 247
775. Figure 8.26: Orthovita's Business Performance, 2005-2009 255
776. Figure 8.27: Sangamo's Investment in Research and Development, 2007-2009 268
777. Figure 8.28: Sangamo's Business Performance, 2005-2009 268
780. INDEX OF TABLES
782. Table 2.1: Number of TERM Companies Identified in the Five Focus Countries, 2009 25
783. Table 2.2: Number of TERM Companies Developing Stem Cells Seeded to Scaffolds, 2009 25
784. Table 2.3: Number of Firms with Focus on Skin, Cartilage, Bone and Urological Applications, 2009 26
785. Table 2.4: Number of Firms Focusing on Cardiovascular Applications, 2009 27
786. Table 2.5: Number of Firms with a Focus on Neurological Applications, 2009 27
787. Table 2.6: Number of Firms Focused on Pancreas, Liver and Kidney Applications, 2009 28
788. Table 2.7: Number of Companies Focused on Autologous and Allogeneic Products, 2009 28
789. Table 2.8: Geographic Distribution of 37 U.S. TIRM Firms, 2009 29
790. Table 2.9: Geographic Location of 11 out of 13 TERM Firms in Japan, 2009 30
791. Table 2.10: Geographic Distribution of the Three TERM Firms in Sweden, 2009 31
792. Table 2.11: Number of Patients Treated with Cell Therapeutics, 1988-2010 33
793. Table 2.12: Some Selected Suppliers of In vitro Test Kits and Their Products 35
794. Table 2.13: Suppliers of Cells and Tissues 36
795. Table 2.14: Selected Suppliers of Media and Reagents 37
796. Table 2.15: Selected Providers of Equipments in Stem Cell Research 37
797. Table 2.16: Selected Providers of Computer Software for Stem Cell Research 39
798. Table 2.17: Geographical Distribution of Stem Cell-related Tissue Engineering Companies, 2008 41
799. Table 2.18: Breakdown of Cell Therapy Firms by Country, 2008-2009 43
800. Table 2.19: Cell Therapy Products on the Market by Type and Application Area, 2008-2009 44
801. Table 2.20: Data on Sales and Application for Skin and Cartilage Products, 2006-2008 45
802. Table 2.21: Reagent Sales by Selected Stem Cell Companies, 2008 46
803. Table 2.22: Sales of Secondary Products, 2007 46
804. Table 2.23: Disease Focus of Clinical Trials, 2008-2009 48
805. Table 2.24: Stem Cell Products in Phase II/III Trials, 2008-2009 49
806. Table 2.25: Licensing Activities in Pharmaceutical and Cell Therapy Industries 54
807. Table 2.26: Investment Activity in Cell Therapy Sector 54
808. Table 2.27: Novel Partnership by Large Pharmaceuticals with Universities 54
809. Table 2.28: Cell Therapy Companies with Greater than Ten Million by Market Cap, 2008 55
810. Table 3.1: Regenerative Medicine Product Development Status, 2008 62
811. Table 3.2: Top Ten Regenerative Medicine Products, 2008 66
812. Table 3.3: Wound Healing Products 72
813. Table 4.1: Worldwide Estimates of Key Industry Parameters, 2007 83
814. Table 4.2: Potential U.S. Populations for Cell-based Therapies 84
815. Table 5.1: The Required Elements of a Manufacturing Facility 94
816. Table 5.2: Cell Therapy CMO Qualification Audit: Points to Investigate 95
817. Table 6.1: Diseases with Potential Applications for Regenerative Medicine 97
818. Table 7.1: Stem Cell Policies in North America 104
819. Table 7.2: Stem Cell Policies in South America 105
820. Table 7.3: Stem Cell Policies in Europe 106
821. Table 7.4: Stem Cell Policies in Asia/Oceania 107
822. Table 7.5: CIRM Funded Grants To-Date 108
823. Table 7.6: List of Upcoming Request for Applications (RFAs) Showing Commitments from Funding Partners 110
824. Table 7.7: Recipients of Funds from Connecticut Stem Cell Research Program, 2009 112
825. Table 7.8: Maryland Stem Cell Research Fund, 2008 114
826. Table 7.9: NJCST's Award of Grants for Stem Cell Research, 2008 114
827. Table 7.10: NYSTEM's IIRP Awards, 2008 115
828. Table 7.11: NIH Funding for Regenerative Medicine and Stem Cell Research, 2003-2009 119
829. Table 7.12: NIH Funding for Various Types of Stem Cell Research, 2004-2009 119
830. Table 8.1: Patents Owned by ACT 124
831. Table 8.2: Patents Owned by ACT's Subsidiary Mytogen, Inc. 124
832. Table 8.3: Patents Licensed to ACT by the University of Massachusetts 124
833. Table 8.4: Alseres' Product Pipeline, 2009 129
834. Table 8.5: Amgen's Pipeline of Products 134
835. Table 8.6: Amgen's Approved Products 135
836. Table 8.7: AnGes' Current Pipeline Status, 2010 144
837. Table 8.8: Angioblast's Product Development Overview 146
838. Table 8.9: Angion's Product Pipeline 146
839. Table 8.10: Angion's Product Pipeline 148
840. Table 8.11: Arteriocyte's Product Pipeline 150
841. Table 8.12: Developmental Status of Athersys' Key Programs, 2010 151
842. Table 8.13: Biohearts Pipeline Product Candidates 157
843. Table 8.14: BioLines Product Pipeline, 2010 159
844. Table 8.15: BioMimetic's Current Product Candidates and Target Indications 160
845. Table 8.16: BioMimetic's Clinical Studies 161
846. Table 8.17: BioMimetic's Investment in Research and Development, 2005-2009 161
847. Table 8.18: BrainStorm's Intellectual Property 168
848. Table 8.19: Cardio3's Promising Product Pipeline 168
849. Table 8.20: Cellerix's Product Pipeline 180
850. Table 8.21: Celgene's Leading Product Candidates 183
851. Table 8.22: Private Cord Blood Banking vs. Public Donation 196
852. Table 8.23: Curis' Current Research and Development Programs and Their Status 197
853. Table 8.24: Curis' Revenues from Research and Development, 2008 and 2009 198
854. Table 8.25: Regulatory Status of Celution System 199
855. Table 8.26: Regulatory Status of PureGraft and CelBrush 200
856. Table 8.27: Develogen's Pipeline Overview 202
857. Table 8.28: Epistem's Emerging Pipeline of Protein Therapeutics 207
858. Table 8.29: FivePrime's Product Pipeline 209
859. Table 8.30: FivePrime's Collaborations 209
860. Table 8.31: Gamidia's Pipeline Products 211
861. Table 8.32: Genzyme's Pipeline of Products 217
862. Table 8.33: Cancer Therapeutics and Diagnostic Products being Developed by Geron 219
863. Table 8.34: The hESC-derived Product Candidates Developed by Geron and its Collaborators 219
864. Table 8.35: Geron's Patent Portfolio 220
865. Table 8.36: Hydra's Product Pipeline 225
866. Table 8.37: Intercytex' Product Pipeline 225
867. Table 8.38: Kiadis' Product Pipeline 239
868. Table 8.39: NeuralStem's Issued and Pending Patents 245
869. Table 8.40: NeuroNova's Product Pipeline 246
870. Table 8.41: Orthovita's Existing Orthobiologic and Biosurgery Products 252
871. Table 8.42: Orthovita's Biosurgery Products 254
872. Table 8.43: Osiris' Therapeutic Product Pipeline 257
873. Table 8.44: Pervasis' Product Pipeline 259
874. Table 8.45: RegeneRx's Product Development Pipeline 261
875. Table 8.46: Summary of Sangamo's Current Clinical Programs 266
876. Table 8.47: Current Status of StemCells' Therapeutic Product Development Programs 269
877. Table 8.48: StemCells' Cell Culture Products 270
878. Table 8.49: StemCells' Patents Covering Stem and Progenitor Cells and Research Tools 271
879. Table 8.50: t2cure's Product Development Pipeline 276
880. Table 8.51: Tengion's Product Candidates Pipeline 277
881. Table 8.52: Thermogenisis' Business Performance by Geographic Area, 2007-2009 279