Chronic Kidney Disease and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains
The ClinicalTrials.gov registry holds 35 records for HSCT in Chronic Kidney Disease: 2 recruiting now, 4 labelled Phase 3 or 4, across 19 countries. Snapshot 2026-08-29.
Why this is studied in Chronic Kidney Disease
Chronic kidney disease is progressive nephron loss with fibrosis and inflammation. Cell approaches aim to slow decline rather than regenerate nephrons, and the kidney's limited regenerative capacity makes restoration claims implausible. Registered work sits close to nephrology practice, which means endpoints are unusually well defined compared with softer indications.
What HSCT means in this table
Haematopoietic transplantation is the oldest and most consequential cell therapy in medicine, with conditioning regimens that carry real mortality risk alongside genuine disease-modifying power. Registrations under this label therefore mix decades-old standard-of-care protocols with newer autoimmune-reset trials, and the risk profile is nothing like that of an outpatient infusion.
The numbers
Every figure below comes from one reproducible query (chronic kidney disease x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 35 |
| Interventional studies in the sample | 33 |
| Recruiting right now | 2 |
| Completed | 23 |
| Terminated, withdrawn or suspended | 2 |
| Phase 3 or Phase 4 records | 4 |
| Countries with at least one site | 19 |
| Median planned enrolment | 30 participants |
| Largest single planned enrolment | 2,663 participants |
| First / most recent start year | 1995 — 2026 |
How mature is this evidence?
Evidence here is mid-maturity: a handful of Phase 3 or 4 registrations (4 of 35) sit above a much larger early-phase base.
Completion status: 23 completed, 2 stopped early (6% of all records). A registration is a plan, not a result.
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 17 | 40% |
| Phase 1 | 12 | 28% |
| Not applicable | 9 | 21% |
| Phase 3 | 4 | 9% |
| Early Phase 1 | 1 | 2% |
Median planned enrolment is 30 participants (largest single study: 2,663). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.
Where the studies are
19 countries host at least one site. United States is the largest single contributor at roughly 60% of country mentions in this sample.
| Country | Studies with a site there |
|---|---|
| United States | 27 |
| Germany | 4 |
| Italy | 4 |
| Spain | 2 |
| Australia | 2 |
| Canada | 2 |
| India | 1 |
| Switzerland | 1 |
| Denmark | 1 |
| Moldova | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
The sponsor mix is commercial (6 academic or hospital, 15 commercial among the most frequent lead sponsors).
- Fred Hutchinson Cancer Center — 11 records
- Children's Oncology Group — 3 records
- University of California, Los Angeles — 2 records
- University of California, San Francisco — 2 records
- Masonic Cancer Center, University of Minnesota — 2 records
- International Stemcell Services Limited — 1 record
Representative registered studies
Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07607197 — Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET) | Phase 1, Phase 2 | Recruiting | 10 | Hospital Universitari Vall d'Hebron Research Institute | 2024-02-01 |
| NCT05525507 — Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants | Phase 1 | Recruiting | 10 | University of California, Los Angeles | 2022-12-21 |
| NCT05806749 — Immunological Tolerance in Patients With Mismatched Kidney Transplants | Phase 1 | Active Not Recruiting | 16 | University of California, Los Angeles | 2023-07-07 |
| 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 |
| NCT00045292 — Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation | Phase 3 | Completed | n/a | Fred Hutchinson Cancer Center | 2002-04 |
| NCT00014391 — Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation | Phase 3 | Completed | n/a | Fred Hutchinson Cancer Center | 1999-02 |
| NCT00004230 — Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation | Phase 3 | Completed | 35 | Northwestern University | 1999-10 |
| NCT01152411 — Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Chronic Renal Failure | Phase 1, Phase 2 | Unknown | 5 | International Stemcell Services Limited | 2010-02 |
| NCT00617929 — Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant | Phase 2 | Terminated | 12 | Masonic Cancer Center, University of Minnesota | 2008-01 |
| NCT00659620 — Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy | Phase 1, Phase 2 | Unknown | 20 | Fuzhou General Hospital | 2008-05 |
What this page does and does not tell you
These figures describe effort, not outcome. Published results, with their control arms and endpoints, are where benefit is decided.
If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.
Frequently asked
How many HSCT studies for Chronic Kidney Disease are recruiting right now?
2 of 35 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is HSCT an approved treatment for Chronic Kidney Disease?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 35 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on HSCT for Chronic Kidney Disease?
4 of 35 records carry a Phase 3 or Phase 4 label and 23 are marked completed. Registrations run from 1995 to 2026.
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
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.