Only one cellular therapy for diabetes is FDA-approved: Lantidra, a donor-derived pancreatic islet cell product approved in 2023 for a small group of adults with type 1 diabetes. It is not the same as the “stem cell therapy for diabetes” sold by many clinics. This guide explains the difference between the one approved product, the unapproved infusions marketed much more widely, and the investigational therapies still being studied in clinical trials.
Lantidra: the one FDA-approved product
Lantidra (donislecel) is a cellular therapy made from donated pancreatic islet cells — the insulin-producing cells that fail in type 1 diabetes — infused into the recipient’s liver. The FDA approved it in 2023 for adults with type 1 diabetes who have repeated episodes of severe low blood sugar despite intensive management, a specific and relatively small patient group.
Lantidra is not a stem cell product; the islet cells come directly from deceased donors rather than being grown from stem cells. Recipients require lifelong immune-suppressing medication to prevent rejection of the donor cells, and the FDA’s approval does not describe it as a cure — some recipients reduce or eliminate insulin use, others do not. Because it is FDA approved for this specific population, it can be covered by insurance for eligible patients, unlike anything discussed below.
VX-880: the investigational stem-cell-derived therapy
A genuinely stem-cell-derived approach is further along than most: Vertex Pharmaceuticals’ VX-880 grows insulin-producing islet cells from stem cells in a lab, then infuses them into people with type 1 diabetes. It entered a pivotal Phase 3 trial in late 2024, and Vertex has targeted a regulatory submission to the FDA in 2026.
As of this writing, VX-880 is still investigational — available only to trial participants, not sold or offered by any clinic. If it is approved, it would become the second FDA-approved cellular therapy for type 1 diabetes, and the first genuinely derived from stem cells. Watch this space rather than any private clinic claiming to offer an equivalent product today.
What the widely marketed ‘stem cell therapy for diabetes’ actually is
Separately from Lantidra and VX-880, a large number of private clinics — inside and outside the US — market IV infusions of mesenchymal stem cells (MSCs) directly to people with type 1 or type 2 diabetes, often advertised simply as “stem cell therapy for diabetes.” These are not the same product as either therapy above, are not delivered through a registered FDA trial, and have no FDA-approved evidence of lowering blood sugar durably or reducing insulin need.
These infusions are the kind of unapproved regenerative-medicine product the FDA has broadly warned consumers about, noting risks including infection and unpredictable immune reactions from unregulated cell products.
Stem cell therapy for diabetic foot ulcers
Stem cell therapy for diabetic foot ulcers is not approved by the Food and Drug Administration (FDA), though pooled clinical trials report higher odds of healing compared to standard care. Diabetic foot ulcers represent a leading cause of lower-limb amputation among people with diabetes. A March 2026 systematic review and meta-analysis in Frontiers in Endocrinology evaluated 32 randomized controlled trials covering 2,059 patients who received autologous bone-marrow-derived mesenchymal stem cells.
Patients in the treated groups had higher odds of ulcer healing than those receiving standard care (odds ratio 4.64). The pooled trials also reported roughly 71 percent lower odds of amputation for treated patients, and the review found average wound healing time dropped by nearly 17 days.
These statistical signals do not prove tissue repair. The review authors identified a high risk of performance and detection bias because most trials were not blinded, allocation concealment was unclear in most trials, and the pooled healing data showed moderate heterogeneity.
No stem cell product holds FDA approval for diabetic foot ulcers. Lantidra is approved only for type 1 diabetes with severe hypoglycemia and does not treat foot wounds. If a clinic offers you this treatment outside a registered clinical trial, check our clinic red-flag checklist before paying out of pocket.
What each option costs
| Option | FDA status | Typical cost | Insurance |
|---|---|---|---|
| Lantidra (donor islet cells) | Approved (narrow type 1 group) | ~$300,000 | Possible, for eligible patients |
| VX-880 (stem-cell-derived islets) | Investigational — trial only | Not sold; trial-only | N/A |
| Private-clinic MSC infusion | Not approved | Several thousand – $20,000+ per round | Never covered |
The unapproved infusions are priced far lower than Lantidra per visit, which can make them look like the “affordable” option. That framing skips the fact that Lantidra has actual approved evidence behind it while the private-clinic infusion does not — you are comparing a proven, covered product against an unproven, self-pay one, not two versions of the same thing.
Why the confusion matters for people managing diabetes
Proven diabetes management — insulin, other approved medications, glucose monitoring, and diet and activity changes — remains the evidence-based foundation of care for both types of diabetes. The risk in an unapproved “stem cell” infusion is not just the money: a false sense that the infusion is managing your blood sugar can lead someone to loosen up on monitoring or medication that is actually keeping them safe.
If you are a candidate for Lantidra or want to ask about enrolling in the VX-880 trial, that conversation belongs with an endocrinologist, not a direct-to-consumer clinic. Our clinic red-flag checklist covers the warning signs common to unapproved regenerative-medicine offers across every condition, diabetes included.
The bottom line
Only one cellular therapy for diabetes, Lantidra, carries FDA approval, and only for a narrow group of type 1 patients with severe hypoglycemia; a genuinely stem-cell-derived option, VX-880, is still in trials with a possible 2026 filing. Everything else marketed as “stem cell therapy for diabetes” — the version most clinics actually sell — is an unapproved MSC infusion with no proven blood-sugar benefit, priced at several thousand dollars or more per round and never covered by insurance.
VX-880’s targeted 2026 filing is not a guarantee, so there is no fixed date to wait for. The concrete next step is to ask an endocrinologist whether you qualify for Lantidra now, rather than spending on a private-clinic infusion or waiting indefinitely on VX-880’s still-pending trial.
Ask which of these three you are actually being offered before you consider paying for any of them.
Frequently asked questions
Is stem cell therapy FDA approved for diabetes?
One cellular therapy is: Lantidra (donislecel), an allogeneic (donor-derived) pancreatic islet cell product the FDA approved in 2023 for a narrow group of adults with type 1 diabetes and severe, uncontrolled low blood sugar. It is not a stem cell product and is not approved for type 2 diabetes. Any other 'stem cell therapy for diabetes' offered outside a registered clinical trial is not FDA approved.
Does stem cell therapy cure diabetes?
No. Lantidra can let some recipients reduce or stop insulin, but it requires lifelong immune-suppressing drugs and is not described as a cure. Clinic-marketed mesenchymal stem cell infusions for diabetes have no FDA-approved evidence of curing or reversing either type of diabetes.
What is Vertex's VX-880 stem cell diabetes therapy?
VX-880 is an investigational, lab-grown pancreatic islet-cell therapy derived from stem cells, made by Vertex Pharmaceuticals. It reached a pivotal Phase 3 trial for type 1 diabetes, with a regulatory submission to the FDA targeted for 2026. As of this writing it is still investigational and not available outside the trial.
How much does stem cell therapy for diabetes cost?
Lantidra is reported to cost roughly $300,000 and may be covered by insurance for eligible patients, since it is FDA approved. Unapproved 'stem cell' infusions sold by private clinics for diabetes are not standardized, commonly cost several thousand to over $20,000 per round, are never covered by insurance, and often recommend repeat treatments.
Is stem cell therapy for type 2 diabetes FDA approved?
No. Lantidra's approval is specific to a narrow group of type 1 diabetes patients with severe hypoglycemia. No stem cell or islet cell product is FDA approved for type 2 diabetes, so any clinic marketing a stem cell treatment for type 2 diabetes is offering an unapproved product.
What are the risks of an unregulated stem cell infusion for diabetes?
Because these infusions are unregulated, cell sourcing and manufacturing standards vary widely. Reported risks include infection, immune reactions, and a false sense of security that delays proven diabetes management such as insulin, medication, and monitoring. There is no evidence any of them lower blood sugar durably.
What are the risks of the immune-suppressing drugs Lantidra requires?
Lifelong immunosuppressive medication lowers the body's defenses and increases susceptibility to serious infections. Over time, these drugs also raise the long-term risk of certain cancers, which is a standard safety tradeoff across transplant medicine.
Did China cure diabetes with stem cells?
No, one patient in an early trial is not a diabetes cure available to the public. A September 2024 report in Cell documented one patient with type 1 diabetes who reached insulin independence starting 75 days after receiving islet cells grown from her own cells. Clinic-sold mesenchymal infusions are a different product that is not FDA approved for diabetes, and our clinic red-flag checklist explains how to evaluate provider claims.
Is a refund available if a private-clinic diabetes stem cell infusion doesn't work?
No standardized or FDA-regulated refund policy exists for these infusions, and most private clinics do not guarantee your money back if your blood sugar doesn't improve. You pay out of pocket regardless of outcome, and any refund terms depend entirely on the individual clinic's own policy. Review all paperwork against our clinic red-flag checklist before you pay a deposit.
Medical disclaimer. Medical Frontier is an independent educational resource. This page is for general information only and is not medical advice, diagnosis, or treatment, and does not create a doctor–patient relationship. Most regenerative therapies discussed here are not FDA-approved for the uses described and may be offered under limited exemptions or in clinical trials only. Always consult a licensed physician before making any treatment decision.