Search for stem cell therapy and you will find clinics in the U.S. and abroad describing similar treatments in similar language. The differences that affect your care sit underneath: where the cells come from, who regulates the clinic, how the laboratory documents each batch, and which physician decides whether you are a candidate.
This guide explains what FDA approval covers in the United States, how umbilical cord cell therapy is regulated in the Dominican Republic, and the questions our physicians suggest you ask any clinic before you plan travel.
What the FDA has approved
In the United States, cells that are grown (expanded) in a laboratory before use are regulated as biological drugs. A clinic can offer them only as an FDA-approved product or inside a clinical trial. Our overview of U.S. availability explains how these rules apply to umbilical cord mesenchymal stem cells (UC-MSCs).
The approved list is short. Cord blood products such as Hemacord and Allocord are licensed for transplants that rebuild the blood-forming system, mostly in patients with blood cancers and inherited blood disorders. In December 2024, the FDA approved Ryoncil (remestemcel-L), a bone marrow-derived mesenchymal stromal cell product, for children with steroid-refractory acute graft-versus-host disease. No UC-MSC product is FDA-approved for joint, spine, autoimmune, or neurological conditions.
For a U.S. patient with one of those conditions, the domestic route to UC-MSC therapy is a clinical trial. Trials enroll narrow patient groups at a limited number of sites.
How treatment works outside the U.S.
Some countries permit licensed clinics to administer culture-expanded UC-MSCs under physician supervision. The Dominican Republic is one of them; its regulator is the Ministry of Public Health and Social Assistance (MISPAS). Expansion lets a laboratory grow cells from screened donor tissue to a counted, documented dose.
Regulation outside the U.S. is uneven. The same treatment name can describe very different products from one clinic to the next, so a national health license is where your review starts.
| FDA-approved products (U.S.) | Licensed clinics in the Dominican Republic | |
|---|---|---|
| Regulator | U.S. Food and Drug Administration | Ministry of Public Health (MISPAS) |
| Approved or permitted uses | Blood-system transplants using cord blood. One MSC product for pediatric graft-versus-host disease | Physician-directed UC-MSC protocols within the clinic's license |
| Cell expansion | Allowed only for an approved product or within a clinical trial | Allowed under national regulation |
| Published evidence | Reviewed by the FDA for each approved use | Varies by condition, from randomized trials to early-phase studies |
| Travel | Not required | Required |
Pros & Cons: FDA-Approved vs. International Allogeneic Umbilical Cord Stem Cells
Latin America, especially some countries like Colombia, Dominican Republic, and Brazil, has emerged as a hub for high-quality umbilical cord mesenchymal stem cell therapies. Many clinics here meet or exceed international standards, with robust regulatory oversight, highly trained medical professionals, and modern facilities. Colombia and the Dominican Republic, in particular, have earned reputations for excellence and strong medical governance, making them reliable choices for international patients.
Important: Always verify that the clinic you choose complies with local health authority regulations, follows strict quality protocols, and provides transparent information about their treatments. Not all countries or clinics offer the same level of safety or efficacy, so trust established centers in countries with strong medical oversight.
Questions to ask any clinic
Our physicians suggest putting these questions to every clinic you are considering, OmniStem included. Ask for the answers in writing before you plan travel.
- Which health authority licenses the clinic, and will the clinic share a copy of that license?
- Where does the donor tissue come from, and what consent and screening does each donor go through?
- Does each batch come with a certificate of analysis showing cell count, viability, and sterility results?
- Was the batch processed in a laboratory that follows Good Manufacturing Practice (GMP)?
- Which physician reviews your medical records, and what is their specialty?
- What outcome does the physician expect for your condition, and which published studies support that expectation?
- Who follows up with you after treatment, and on what schedule?
Patient accounts, such as those on our testimonials page, describe what treatment is like. A physician’s review of your records is what tells you whether treatment fits your case.
Frequently asked questions
Is umbilical cord stem cell therapy safe?
Every treatment carries risk, and that risk depends on the product, how it was processed, and the patient receiving it. Published research on mesenchymal stromal cells (MSCs) shows what to expect. A 2021 meta-analysis of 62 randomized trials with 3,546 participants linked MSC treatment to transient fever, reactions at the administration site, constipation, fatigue, and sleeplessness. A 2020 meta-analysis found no increased risk of infection, blood clots, death, or malignancy compared with control groups. Before any treatment, our physicians review your history for factors that would change that picture for you.
Does the ISSCR accredit stem cell clinics?
No. The International Society for Stem Cell Research (ISSCR) publishes guidelines for stem cell research and its clinical translation. It does not accredit or certify clinics. A clinic can say it follows ISSCR guidelines; a claim of ISSCR accreditation is inaccurate.
Why do patients travel for stem cell therapy?
Usually for access. For orthopedic, autoimmune, and neurological conditions, UC-MSC therapy is available in the U.S. only through clinical trials. Patients who do not qualify for a trial, or who live far from one, look at licensed clinics abroad.
Is stem cell therapy legal outside the U.S.?
It depends on the country. In the Dominican Republic, licensed clinics can administer UC-MSC therapy under MISPAS regulation. Rules differ elsewhere, so confirm the license in the country where you would be treated.
Are results guaranteed?
No. Outcomes depend on the condition, how advanced it is, your overall health, and the protocol your physician selects. A clinic that promises a specific result is a reason to keep looking.
Will I need more than one treatment?
Some protocols use a single administration; others are planned as a series. Your physician sets the plan after reviewing your records and, where relevant, your imaging.
How much does treatment cost?
Cost depends on the protocol, the cell dose, and the number of sessions. OmniStem quotes each program after the medical evaluation, and our cost guide explains what drives the range. Insurance rarely covers UC-MSC therapy, in the U.S. or abroad.
Every plan starts with a physician
At OmniStem, a physician reviews your medical records before any treatment is discussed. The Regenerative Evaluation collects your history, current medications, and imaging. Our medical team uses it to decide whether you are a candidate and which protocol fits your case, and tells you when UC-MSC therapy is unlikely to help.
The questions above apply to every clinic, ours included.
Educational material only. This article does not replace individualized medical advice, diagnosis, informed consent, or treatment by a qualified physician. Regenerative therapies require medical evaluation. Outcomes vary by patient, condition, and protocol. OmniStem does not diagnose, treat, cure, or guarantee reversal of any disease or symptom.
