Funded Awards

The awardees funded by the Regenerative Medicine Innovation Project (RMIP) in FY 2021 include:

Johns Hopkins University, Maryland
Luis Andres Garza, M.D., Ph.D.
Injection of Autologous Volar Fibroblasts to the Stump Site to Allow Pressure Adaptation and Enhanced Prosthetic Use in Amputees
GRANT Number: 1UG3AR079376-01

The awardees funded by the Regenerative Medicine Innovation Project (RMIP) in FY 2020 include:

Regenerative Research Foundation, New York
Jeffrey H. Stern, M.D., Ph.D.
Phase 1/2a Clinical Trial of RPESC-Derived RPE Transplantation As Therapy For Non-Exudative Age-Related Macular Degeneration
GRANT Number: 1UG3EY031810-01

University of Illinois at Chicago, Illinois
Ali R. Djalilian, M.D.
Phase I Study Of Mesenchymal Stromal Cell Secretome For Promoting Corneal Regeneration
GRANT Number: 1UG3EY031809-01

Steadman Philippon Research Institute, Colorado
Johnny Huard, Ph.D.
The Use Of Senolytic And Anti-Fibrotic Agents To Improve The Beneficial Effect Of Bone Marrow Stem Cells For Osteoarthritis
GRANT Number: 1UG3AR077748-01

NIH is pleased to announce the research awards funded through the NIH Regenerative Medicine Innovation Project (RMIP) for this year. The awardees funded by the RMIP in FY 2019 include:

Late Stage Investigational New Drug (IND) - or Investigational Device Exemption (IDE) Enabling Pre-clinical Studies:

Boston University Medical Campus, Massachusetts
Darrell N. Kotton, M.D.
Generation of Functional Lung Stem Cells from Human IPSCS
GRANT Number: 1U01HL148692-01

Columbia University, New York
Stephen H. Tsang, M.D., Ph.D.
Precision genome surgery in autologous stem cell transplant
GRANT Number: 1U01EY030580-01  

Mayo Clinic Rochester, Minnesota
lan D. Marmorstein, Ph.D.
Preclinical testing of iPSC derived retinal pigment epithelium to treat macular degeneration
GRANT Number: 1U01EY030547-01

Neural Stem Cell Institute, New York
Jeffrey H. Stern, M.D., Ph.D.
Transplantation of Adult, Tissue-Specific RPE Stem Cells as Therapy for Non-exudative Age-Related Macular Degeneration AMD
GRANT Number: 1U01EY030581-01

University of Colorado Denver, Colorado
Dennis Roop, Ph.D.
Exploring Alternative iPS Cell Therapies for Recessive Dystrophic Epidermolysis Bullosa
GRANT Number: 1U01AR075932-01

University of Wisconsin-Madison, Wisconsin
Timothy J. Kamp, M.D., Ph.D
Committed Cardiac Progenitors to Remuscularize the Failing Ischemic Heart
GRANT Number: 1U01HL148690-01

Wake Forest University, North Carolina
Graca Duarte Almeida-Porada, M.D., Ph.D
CGMP Manufacture of FVIII-Expressing Placental Cells for Hemophilia A
GRANT Number: 1U01HL148681-01

Early Phase Clinical Trial:

The Research Institute at Nationwide Children's Hospital, Ohio
Christopher K. Breuer, M.D.
A Study Evaluating the Safety and Efficacy of Second-Generation Tissue Engineered Vascular Grafts (TEVG2)
GRANT Number: 1-UG3-HL-148693-01

In September 2017, eight research proposals involving adult stem cells were selected for funding through the RMIP. These projects cover a broad spectrum of science and new technologies, and have the potential to advance understanding and treatment of common diseases – including diabetes, anemia, corneal and other eye diseases, and chronic skin ulcers -- as well as rare diseases, including idiopathic pulmonary fibrosis, inherited skin diseases, and sickle cell disease.

Several awards explored the use of adult stem cells to make specialized cells and tissues that could help reduce the need for whole organ transplants or otherwise restore normal function. Others aimed to develop reliable methods of generating red blood cells and platelets in the lab to improve the safety and supply of blood available for transfusion.

The awardees funded by the Regenerative Medicine Innovation Project in FY 2017 include:

Albert Einstein College of Medicine, New York
Eric E. Bouhassira, Ph.D.
Optimization of Reagent Red Blood Cell Production
GRANT Number: 5-R01-H-130764-04

Boston Children’s Hospital, Massachusetts
Markus H. Frank, M.D.
ABCB5-Positive Stem Cells for Limbal Stem Cell Deficiency (LSCD) Therapy
Grant Number: 3-R01-EY-025794-02

Children’s Hospital of Philadelphia, Pennsylvania
Mortimer Poncz, M.D.
Optimization of Ex Vivo- and In Vivo-Generated Platelets
Grant Number: 5-R01-HL-130698-03

Columbia University Health Sciences, New York
Hans-Willem E. Snoeck, M.D., Ph.D.
Modeling, pathogenesis and treatment of idiopathic pulmonary fibrosis
Grant Number: 5-U01-HL-134760-02

Harvard University, Cambridge, Massachusetts
Douglas A Melton, Ph.D.
Production of Clinical-Grade Diabetes Patient-Specific Induced Pluripotent Stem Cell Lines Intended for Autologous Beta Cell Replacement Therapy
Grant Number: 3-UC4-DK-104165-01

Maine Medical Center, Maine
Leif Oxburgh, D.V.M., Ph.D.
Engineering Erythropoietin-Producing Cells
Grant Number: 3-R24-DK-106743-03

University of Colorado Denver, Colorado
Dennis Roop, Ph.D.
Testing the Therapeutic Potential of iPS Cells for Inherited Skin Diseases
Grant Number: 3-R01-AR-059947-05

Yale University, Connecticut
Mark W. Saltzman, Ph.D.
Optimizing Therapeutic Revascularization by Endothelial Cell Transplantation
Grant Number: 5-R01-HL-085416-12

2017 Regenerative Medicine Innovation Workshop

This workshop, hosted in December 2017 by NIH and FDA, brought together key stakeholders to explore the state of regenerative medicine clinical research involving adult stem cells with a focus on approaches to the development of safe and effective products. Video recordings (link is external) from each session are available. The deliberations were instrumental in helping to identify some of the major needs, opportunities, and challenges in the regenerative medicine field.

Participants identified a number of critical challenges in RM, including:

• Limited understanding of the identity and nature of stem cell products used in clinical applications;
• The need for effective methods for tracking and monitoring stem cell products in vivo; the need for regulatory “coaching” support to enable submission of well-supported IND/IDE applications;
• Difficulties in obtaining assistance with preparation of current Good Manufacturing Practice (cGMP)-compliant stem cell products;
• The need for improved data sharing; and
• The importance of forging key RM partnerships and collaborations.