What research stage is stem-cell therapy for Chronic Kidney Disease at?
Of 88 registrations, 10 reached a confirmatory phase label; everything else is earlier-stage or unlabelled (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 42 | 40% |
| Phase 2 | 30 | 29% |
| Not applicable | 20 | 19% |
| Phase 3 | 6 | 6% |
| Phase 4 | 4 | 4% |
| Early Phase 1 | 2 | 2% |
What the phase mix means for Chronic Kidney Disease
Later-phase designs exist here more than in most soft-tissue indications, because eGFR slope is a quantifiable, regulator-recognised endpoint. That makes CKD one of the better places to judge whether cell therapy can survive a properly powered comparison.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| 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 |
| NCT01155128 — Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease | Phase 4 | Unknown | 200 | Federal University of Pelotas | 2011-09 |
| NCT00182559 — The Vienna Prograf and Endothelial Progenitor Cell Study | Phase 4 | Completed | 148 | Medical University of Vienna | 2004-04 |
| NCT00538850 — Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain | Phase 3 | Completed | 130 | INSYS Therapeutics Inc | 2007-10 |
| NCT01265615 — Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients | Phase 4 | Completed | 109 | Ural State Medical University | 2009-10 |
How to read phase labels
Phase 1 asks whether a dose is tolerated, usually in a small group without a control arm. Phase 2 looks for a signal and refines dosing. Phase 3 is confirmatory: larger, controlled, powered to test whether the intervention changes an outcome that matters. Not applicable appears for observational studies or where the sponsor assigned no phase, which is common in cell therapy and not a quality mark either way.
Median planned enrolment across sampled studies here is 31 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03899298 — Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions | Phase 1 | Not Yet Recruiting | 5,000 | R3 Stem Cell | 2019-09-01 |
| NCT02639936 — New Generation IGRA in Immunocompromised Individuals | n/a | Completed | 2,663 | Tuberculosis Network European Trialsgroup | 2015-12 |
| NCT00949052 — Genetic Susceptibility and Risk of Second Cancers in Patients Who Have Undergone Stem Cell Transplant for Cancer | n/a | Terminated | 1,000 | Vanderbilt-Ingram Cancer Center | 2009-01 |
| 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 |
| NCT00957736 — Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant | n/a | Terminated | 252 | Vanderbilt-Ingram Cancer Center | 2008-11 |
Frequently asked
What research stage is stem-cell therapy for Chronic Kidney Disease at?
10 of 88 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
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