How strong is the evidence for stem-cell therapy in Chronic Kidney Disease?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: the registry holds 88 records, 52 completed, 10 at Phase 3 or 4, and 6 stopped early (7%). MSC-specific work accounts for 23 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Chronic Kidney Disease
The endpoint that counts is change in eGFR slope or time to a hard renal event over at least a year, against a control on standard therapy. Single creatinine readings move with hydration, diet and blood pressure, so a post-infusion 'improvement' at one visit means nothing.
What we can say from registrations alone
- Volume: 88 registered studies since 1994.
- Maturity: 10 confirmatory-phase records.
- Delivery: 52 completed; 6 terminated, withdrawn or suspended.
- Scale: median planned enrolment 31 participants, largest 5,000.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02639936 — New Generation IGRA in Immunocompromised Individuals | n/a | Completed | 2,663 | Tuberculosis Network European Trialsgroup | 2015-12 |
| NCT00003883 — Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation | Phase 3 | Completed | 578 | Fred Hutchinson Cancer Center | 1998-10 |
| NCT01305200 — Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant | Phase 3 | Completed | 226 | Children's Oncology Group | 2011-03 |
| NCT00080873 — Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation | n/a | Completed | 195 | Children's Oncology Group | 2004-04 |
| NCT00365287 — Combination Chemotherapy and Total-Body Irradiation Before Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer | Phase 1, Phase 2 | Completed | 148 | Masonic Cancer Center, University of Minnesota | 2000-06 |
| NCT00182559 — The Vienna Prograf and Endothelial Progenitor Cell Study | Phase 4 | Completed | 148 | Medical University of Vienna | 2004-04 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Chronic Kidney Disease research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Chronic Kidney Disease?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: 88 registered records, 10 at Phase 3/4 and 6 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
That has to be checked per product with the regulator that governs where you would be treated. A clinic's own claim of approval is not verification.
Why do clinics cite hundreds of studies?
Because counting registrations is easy and sounds authoritative. The number that matters is how many controlled studies reported a clinically meaningful outcome for the product being sold.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
More on this condition
- Chronic Kidney Disease: cell-therapy evidence and registered trials
- How much does stem cell therapy for Chronic Kidney Disease cost? (2026)
- Chronic Kidney Disease stem cell therapy — your questions answered (2026)
- Chronic Kidney Disease: cell-therapy evidence by therapy class
- MSC vs HSCT for Chronic Kidney Disease: what the registries show