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  • Review Article
  • Published:

Commercialization of regenerative-medicine therapies


The clinical translation of regenerative-medicine products, including cell therapies, therapeutic tissue engineering products, and human cell and tissue products, remains limited because of the so-called ‘valley of death’, that is, the lack of resources necessary to move a product from early preclinical to clinical development. To advance more regenerative-medicine products into the clinic, academic researchers may benefit greatly from insights into the commercialization process, in particular, through academic startups. In this Review, we discuss key commercialization aspects, that is, protecting intellectual property, navigating regulatory pathways and obtaining funding, and highlight case studies of academic startups that have successfully developed US Food and Drug Administration-approved regenerative-medicine products and companies that have received Regenerative Medicine Advanced Therapy designations for their regenerative-medicine products in development.

Key points

  • Academic researchers interested in translating regenerative-medicine therapies to approved products may benefit from knowing about commercialization aspects early in research and development.

  • Understanding the steps toward establishing intellectual property (IP) within academic institutions is key to conducting and disseminating IP-yielding research.

  • Regenerative Medicine Advanced Therapy (RMAT) designations provide a pathway that can expedite the approval process of regenerative-medicine products.

  • Grants and non-dilutive mechanisms can support preclinical studies, and dilutive mechanisms of funding and initial public offerings are the major sources of financial capital for clinical development phases.

  • Academic institutions and funding agencies should implement policy changes to motivate and drive academic researchers toward the commercialization of regenerative-medicine technologies.

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Fig. 1: Steps toward obtaining patents and disseminating research findings while maintaining patenting rights.
Fig. 2: The FDA regulatory pathway for regenerative-medicine therapies.
Fig. 3: Funding mechanisms for academic startups.

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The authors thank S. Heimann for assistance with database searches of regenerative-medicine companies. The authors acknowledge funding support from the NIH through grants R01DE015038, R01AR071457 and R01AR078389.

Author information

Authors and Affiliations



T.T. conceived the idea for this Review and contributed to researching the data and literature, discussion, writing and editing. R.P.D. and R.C.N. contributed to researching the data and literature, discussion, writing and editing of this manuscript. J.C.H. contributed to the discussion, reviewing and editing of the manuscript. S.C.C. and K.A.A. conceived the idea for this Review and contributed to the discussion, reviewing and editing of the manuscript.

Corresponding author

Correspondence to Kyriacos A. Athanasiou.

Ethics declarations

Competing interests

R.P.D., J.C.H. and K.A.A. are cofounders of and hold equity in Cartilage Inc. The remaining authors declare no competing interests.

Peer review

Peer review information

Nature Reviews Bioengineering thanks István Hornyák, Helen Yu and John Blaho for their contribution to the peer review of this work.

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Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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3/20/2017 (Humacyl):®-in-Vascular-Access-for-Hemodialysis

4/17/2017 (RVT-802:

5/2/2017 (jCell):

5/10/2017 (Ixmyelocel-T):

7/18/2017 (approved as StrataGraft):

2017 (UD):

9/20/2017 (ATIR101):™

10/1/2017 (LentiGlobin approved as Zynteglo for the treatment of beta thalassaemia):

10/2/2017 (AST-OPC1):

10/5/2017 (MultiStem):

11/1/2017 (JCAR017):

11/8/2017 (CEVA101):

12/21/2017 (MPC-150-IM):

1/29/2018 (EB-101):

2/5/2018 (CAP-1002):

3/9/2018 (AminoFix Injectable):

4/23/2018 (ABO-102):

May 2018 (VM-202):

2000 (US$53 M):

6/14/2018 (NSR-REP1):

6/19/2018 (CLBS14):

6/21/2018 (VY-AADC):

7/2/2018 (Romyelocel-L):

8/21/2018 (AT132):

10/11/2018 (Lifileucel):

10/29/2018 (Avance Nerve Graft):

11/5/2018 (P-BCMA-101):

11/27/2018 (RP-L102):

4/18/2019 (FCR-001):

4/23/2019 (ECT-001):

May 2019 (Alofisel):

5/29/2019 (FCX-007):

6/11/2019 (Posoleucel):

6/24/2019 (KB103):

7/5/2019 (SB-525):

7/29/2019 (OTL-103):

8/22/2019 (MB-107):

9/4/2019 (MGTA-456):

9/20/2019 (SB623):

10/28/2019 (CT053):

12/3/2019 (ADP-A2M4):

2/27/2020 (TT11):

4/16/2020 (TTAX02):

4/22/2020 (FDA-approved as Kymriah):

5/6/2020 (Ilixadencel):

5/11/2020 (CTX001):

9/22/2020 (MDR-101):

9/23/2020 (MultiStem):

10/14/2020 (Orca-T):

11/11/2020 (AB205):

12/17/2020 (AMDC-USR):

1/11/2021 (ReNu):

3/8/2021 (valoctocogene roxaparvovec):

3/9/2021 (RP-L201):

4/21/2021 (ALLO-715):

Oct 2021 (REACT):

11/22/2021 (CTX110):

12/13/2021 (FT516):

2022 SPAC merger (UD):

1/5/2022 (Posoleucel):

1/10/2022 (CT041):

1/12/2022 (C-CAR039):

2/14/2022 (AProArt):

4/12/2022 (Exoflo):

4/20/2022 (Posoleucel):

4/25/2022 (Obe-cel):

5/13/2022 (SkinTE):

5/24/2022 (NeoCart):

6/8/2022 (ALLO-501A):

9/28/2022 (CTX130):

11/8/2022 (ADP-A2M4CD8):

11/29/2022 (CB-010):

1/26/2023 (rebonuputemcel):

2/7/2023 (RP-A501):

2/8/2023 (rexlemestrocel-L):

2/11/2023 (CT103A):

3/21/2023 (NTLA-2002):

5/4/2023 (HAV):

5/23/2023 (RP-L301):

5/24/2023 (RGX-121):

1997 (US$20 M):

1999 (US$58 M):

2004 (US$21 M):

2007 (US$56 M):

2007 Reverse merger (UD):

2008 (UD):

2008 Reverse merger (UD):

2011 Reverse merger (UD):

2013 (SEK 21 M):

2013 (US$116 M):

2013 (US$40 M):

2013 Reverse merger (UD):

2013 Reverse merger (UD):

2014 (US$265 M):

2015 (US$124 M):

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2015 (US$36 M):

2015 (US$5.5 M):

2015 (US$81 M):

2016 (US$113 M):

2016 (US$56 M):

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2016 Acquired by Mallinckrodt (UD):

2017 (US$46 M):

2017 (US$77 M):

2017 Reverse merger (UD):

2018 (US$100 M):

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2018 (US$225 M):

2018 (US$373 M):

2018 Acquired by Celgene (US$9,000 M):

2018 Acquired by Takeda Pharmaceutical Company (US$608 M):

2018 Reverse merger (UD):

2018 Reverse merger (UD):

2019 Acquired by Biogen (US$800 M):

2019 Acquired by BioTime (UD):

2019 Acquired by Castle Creek Pharmaceutical (US$63 M):

2019 Acquired by Sumitomo Dainippon Pharma (UD):

2019 Reverse merger (UD):

2020 (US$224 M):

2020 (US$318 M):

2020 Acquired by Astellas Pharma (US$3,000 M):

2021 (US$150 M):

2021 (US$304 M):

2021 (US$400 M):

2021 Acquired by consortium (US$411 M):

2021 Acquired by Sanofi (US$358 M):

2021 Reverse merger (UD):

2022 Acquired by Canaria Bio (UD):

2022 Merger with Cend Therapeutics (UD):

20 cellular and gene therapy products:

21 CFR 312:

525 non-regenerative-medicine drugs:

7% in bank fees for a US$100 million IPO:

86 RMAT designations:

a list and ranking of incubators and accelerators worldwide:

a US$20 million award from the California Institute for Regenerative Medicine (CIRM):

Abecma (2021):


acquired by Celgene:

acquired by Mallinckrodt Pharmaceuticals:

acquired by Novartis:

acquired in a reverse merger:

acquired through a reverse merger:

Adstiladrin (2022):


amount for a seed round:

Analysts consider:

approved as Breyanzi:

approved as Rethymic):

approved by the US Food and Drug Administration:




averages for VC series A, B, and C:


Baylor College of Medicine:;


BLA clinical review:

BLA pharmacology/toxicology review of StrataGraft:

Bluebird Bio (founded as Genetix Pharmaceuticals):

Breyanzi (2021):

California Institute for Regenerative Medicine (CIRM):

cartilage repair products:

Carvykti (2022):

Case Western Reserve University:

cellular immunotherapy product Provenge:

CFR Title 21:

CGT products:

Children’s Hospital of Philadelphia University of Pennsylvania:

City of Hope National Medical Center:

clinical trials:

completed an initial public offering (IPO):

considered safety data generated from the phase I/IIa and phase II trials for an alternate indication:

convertible note:

Cooperative Patent Classification system:

current Good Manufacturing Practice (cGMP) regulations:

Dilution of equity:

Duke University, Massachusetts Institute of Technology:

Duke University:

Duke University:

‘End of Phase’ meetings:

Enzyvant Therapeutics GmbH licenced the technology from Duke University:

established IP:

exceeding US$20 billion in 2021:

excess of these amounts:

FDA approval of JCAR017:

Ferring Pharmaceuticals:

Financial exit strategies:

founded in 2013:

Fred Hutchinson Cancer Center, St Jude Children’s Research Hospital:

Fred Hutchinson Cancer Research Center Memorial Sloan-Kettering Cancer Center Seattle Children’s Research Institute:

Fred Hutchinson Cancer Research Center Memorial Sloan-Kettering Cancer Center Seattle Children’s Research Institute University of California, San Francisco St Jude Children’s Research Hospital:

funding caps:

Genesis Seed Fund:

Gilead Sciences:

Harvard University, Massachusetts Institute of Technology:

Harvard University, Washington University in St Louis, Stanford University, San Raffaele Telethon Institute for Gene Therapy, University of Basel:

Harvard University:

Harvard University:

Hemgenix (2022):

highly competitive:

Imlygic (2015):

INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting:

interpretations of Section 506(g)(8) by the US Food and Drug Administration (FDA):

‘inventive step’:

Investigational New Drug application:



Johns Hopkins University:

Johnson & Johnson:

Juno Therapeutics (founded as FC Therapeutics):

Juno Therapeutics:

Katholieke Universiteit Leuven Ghent University:

Kymriah (2017):


Luxturna (2017):

Luxturna to be approved by the US Food and Drug Administration:


MACI (2016):

Mallinckrodt Pharmaceuticals:

Massachusetts Institute of Technology:

Massachusetts Institute of Technology:


National Cancer Institute:

Nationwide Children’s Hospital Ohio State University:

Nationwide Children’s Hospital:

NIH Data Management and Sharing Policy:

NIH’s Commercialization Readiness Pilot (CRP) programme:

no major safety concerns were generated from the preclinical studies:

NSF-funded Innovation-Corps (I-Corps):

obtained Regenerative Medicine Advanced Therapy designation:

only the phase Ib and phase III trials were considered for efficacy:



over 1,000 new devices:

University of Oxford, University of Pennsylvania:

Patent Cooperation Treaty (PCT):

peak sales forecast:

Phase 0 grants:

pledged a US$50 million commitment from the Children’s Hospital of Philadelphia:

pre-IND meeting:

private equity (PE):

product revenue of Breyanzi:

Promotion and Tenure-Innovation and Entrepreneurship (PTIE) coalition:

Provenge (2010):

quality management system:

raised a total of US$310 million:

raised an additional US$72.8 million in series B funding:

raised US$304 million through its initial public offering:

reason for noncompliance:

Regenerative Medicine Advanced Therapy (RMAT) designation:

Regenerative Medicine Minnesota:

Rethymic (2021):

reverse merger:


Risk Evaluation and Mitigation Strategy programme:


Roughly 90% of applications filed are utility patents:

San Raffaele-Telethon Institute for Gene Therapy:

SBA loans:

SBIR and STTR programmes:

secondary public offerings:

section 361:

Section 506(g)(8) of the United States (US) Federal Food, Drug, and Cosmetic Act:

Seoul National University:

settled a legal dispute:

Several expedited programmes:


Skysona (2022):

Spark Therapeutics:

Stanford University:

Stanford University:

StrataGraft (2021):



subsequently approved:

Sumitomo Pharma:

Tecartus (2020):

technology for Brenyanzi:

technology for StrataGraft:

technology of Zolgensma:

three FDA-approved products:

three types of patent:

“treat, modify, reverse, or cure a serious or life-threatening condition”:


UniQure (founded as Amsterdam Molecular Therapeutics):

Université de Montréal University of Toronto:

University College London:

University of California San Diego (UCSD):

University of California, Berkeley:

University of California, Berkeley:

University of California, Irvine:

University of California, Irvine:

University of California, Los Angeles:

University of California, Los Angeles:

University of California, San Francisco:

University College London:

University of Colorado University of Illinois at Chicago:

University of Eastern Finland:

University of Florida:

University of Florida:

University of Louisville:

University of Massachusetts University of California, San Francisco Stanford University:

University of Minnesota:

University of Oxford:£23-million-boost-oxford-spinout-company

University of Pennsylvania:

University of Pennsylvania:

University of Pennsylvania:

University of Washington, Children’s Hospital Boston Mass General Hospital for Children:

University of Wisconsin:

University of Wisconsin — Madison:

updated the US policy guidance:

US$10 million in series C:

US$13.1 million:

US$34 million:

US$49 million:

US$5.35 million:

US$65 million in series D:

US$65 million through an initial public offering:

US$9.0 million:

Vyjuvek (2023):

Weizmann Institute:

Weill Cornell Medicine:

Western New York Incubator Network SBIR/STTR assistance programme:

Y Combinator Management:

Yescarta (2017):

Zolgensma (2019):

Zynteglo (2022):

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Takahashi, T., Donahue, R.P., Nordberg, R.C. et al. Commercialization of regenerative-medicine therapies. Nat Rev Bioeng 1, 906–929 (2023).

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