Healthcare & Biotech 2026Updated

List of Stem Cell Therapy Clinics with FDA-Approved Clinical Trials

A curated database of medical institutions conducting FDA-registered stem cell clinical trials across the United States, including trial phases, therapeutic areas, and principal investigators — helping referring physicians and researchers identify legitimate programs.

Available Data Fields

Institution Name

Location

Trial Phase

Therapeutic Area

Stem Cell Type

NCT Number

Principal Investigator

FDA IND Status

Enrollment Status

Contact Information

Data Preview

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Institution	Location	Therapeutic Area	Trial Phase
Mayo Clinic	Rochester, MN	Graft-vs-Host Disease, Cardiac Repair	Phase II / III
MD Anderson Cancer Center	Houston, TX	Hematologic Malignancies (HSCT, CAR-T)	Phase I / II / III
City of Hope	Duarte, CA	Blood Cancers, Solid Tumors	Phase I / II
Memorial Sloan Kettering	New York, NY	Hematologic Malignancies, Solid Tumors	Phase I / II
Dana-Farber Cancer Institute	Boston, MA	Leukemia, Lymphoma, Myeloma	Phase I / II / III

800+ records available for download.

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Navigating FDA-Registered Stem Cell Clinical Trials in the United States

The stem cell therapy landscape in the U.S. is sharply divided between legitimate, FDA-registered clinical trials at academic medical centers and a growing number of unregulated clinics offering unapproved treatments. As of late 2025, the FDA has approved 46 cell and gene therapy products, while over 800 institutions are conducting stem cell-related clinical trials registered on ClinicalTrials.gov.

What "FDA-Approved" Actually Means

The FDA does not approve clinics — it approves products and authorizes clinical trials through Investigational New Drug (IND) applications. Currently approved stem cell products are primarily hematopoietic stem cell transplants (from bone marrow, peripheral blood, or cord blood) and newer CAR-T cell therapies for blood cancers. In December 2024, Ryoncil became the first mesenchymal stem cell (MSC) therapy to receive FDA approval, for pediatric steroid-refractory acute graft-versus-host disease.

Key Therapeutic Areas Under Investigation

Oncology & Hematology: HSCT and CAR-T therapies for leukemia, lymphoma, and myeloma remain the largest category, with centers like MD Anderson, City of Hope (20,000+ transplants performed), and Memorial Sloan Kettering leading enrollment.
Neurology: iPSC-derived therapies for Parkinson's disease, ALS, and spinal cord injury are advancing rapidly. In 2025, XellSmart received IND clearance for three separate iPSC-based therapies targeting these conditions.
Ophthalmology: Pluripotent stem cell-derived retinal therapies represent one of the fastest-growing trial categories, with over 115 global PSC trials as of December 2024.
Cardiac & Regenerative: Mayo Clinic's FDA-cleared automated bioreactor platform enables scaled production of bone marrow-derived stem cells for cardiac repair trials.

How to Verify a Clinic's Legitimacy

The FDA's Consumer Alert on Regenerative Medicine warns patients to verify any stem cell treatment through these steps:

Confirm the trial is registered on ClinicalTrials.gov with a valid NCT number
Verify the institution holds an active IND application with the FDA
Check that the clinic is affiliated with an accredited academic medical center or recognized by the National Marrow Donor Program (NMDP)
Be wary of clinics charging patients to participate in "clinical trials" — legitimate trials typically cover treatment costs

Frequently Asked Questions

Q.How is this different from searching ClinicalTrials.gov directly?

ClinicalTrials.gov contains thousands of trials across all categories with complex search filters. This dataset extracts and structures stem cell-specific trial data by institution, making it easier to identify which clinics are running legitimate FDA-registered programs and compare them side by side.

Q.Does this include clinics offering unapproved stem cell treatments?

No. This dataset only includes institutions with trials registered on ClinicalTrials.gov under an FDA Investigational New Drug (IND) application. Unregulated clinics offering unapproved therapies are excluded.

Q.How current is the trial enrollment status?

When you request data, our AI crawls public sources including ClinicalTrials.gov in real time to retrieve the latest enrollment status, ensuring you get up-to-date information rather than a static snapshot.

Q.Can I filter by specific disease or condition?

Yes. You can specify conditions such as ALS, Parkinson's disease, specific cancers, or cardiac conditions to see only institutions running trials relevant to that indication.