Registry evidence

Diabetes (Type 1 & 2) and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains

The ClinicalTrials.gov registry holds 14 records for HSCT in Diabetes (Type 1 & 2): 2 recruiting now, 1 labelled Phase 3 or 4, across 8 countries. Snapshot 2026-08-29.

Medical review statusMedically reviewedReviewed by: Stem Plus medical teamReviewed on: 2026-08-29Last evidence update: 2026-08-29Methodology and editorial standards
Clinical review team: Dr Kamelia Milcheva, Hematologist · Dr Vadym Uvarov, Board-Certified Physician · Hepatobiliary Surgeon · Candidate of Medical SciencesEditorial responsibility: StemCellAtlas research teamEducational information only. This page does not provide medical advice, diagnosis or a treatment recommendation.

Why this is studied in Diabetes (Type 1 & 2)

The registry entries here are dominated by type 1 diabetes, an autoimmune destruction of beta cells. Two distinct strategies appear: immune reset around new-onset disease, and beta-cell replacement from stem-cell-derived islets. The second is the most genuinely transformative line of work in the whole field, and it is also the one most often invoked by clinics offering something entirely different.

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 (type 1 diabetes x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.

MetricValue
Registered studies (all statuses)14
Interventional studies in the sample14
Recruiting right now2
Completed6
Terminated, withdrawn or suspended2
Phase 3 or Phase 4 records1
Countries with at least one site8
Median planned enrolment25 participants
Largest single planned enrolment100 participants
First / most recent start year2003 — 2025

How mature is this evidence?

Later-phase work exists but is not dominant (1 of 14), which is the typical profile of a field that has shown safety and is still testing whether benefit survives a control arm.

Completion status: 6 completed, 2 stopped early (14% of all records). A registration is a plan, not a result.

Phase labelRecordsShare
Phase 21255%
Phase 1836%
Phase 315%
Not applicable15%

Median planned enrolment is 25 participants (largest single study: 100). 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

Country coverage runs to 8, but the distribution has a long tail behind China at about 31% of mentions.

CountryStudies with a site there
China4
Vietnam2
Brazil2
Egypt1
Sweden1
Mexico1
Philippines1
Jordan1

Legal pathway differs by country — see where cell therapy is legal, by country.

Who runs them

The sponsor mix is academic (6 academic or hospital, 2 commercial among the most frequent lead sponsors).

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — 2 records
  • University of Sao Paulo — 2 records
  • Ain Shams University — 1 record
  • Uppsala University Hospital — 1 record
  • Dra. Olga Graciela Cantu Rodriguez — 1 record
  • Adistem Ltd — 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.

StudyPhaseStatusPlanned nLead sponsorStart
NCT06951074 — Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 DiabetesPhase 2, Phase 3Recruiting20Ain Shams University2025-04-01
NCT03835312 — Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DMn/aRecruiting50Children's Hospital of Fudan University2019-02-20
NCT03484741 — Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus PatientsPhase 1, Phase 2Unknown15Van Hanh General Hospital2017-04-01
NCT02057211 — Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized StudyPhase 2Terminated10Uppsala University Hospital2014-04
NCT02644759 — Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes MellitusPhase 1, Phase 2Completed100Stem Cells Arabia2014-02
NCT01121029 — Hematopoietic Stem Cell Transplantation in Type 1 Diabetes MellitusPhase 1, Phase 2Completed15Dra. Olga Graciela Cantu Rodriguez2010-05
NCT01285934 — Hematopoietic Stem Cell Support Versus Insulin in T1DPhase 1, Phase 2Withdrawnn/aNorthwestern University2009-01
NCT02763423 — Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic KetoacidosisPhase 2Unknown30The Affiliated Nanjing Drum Tower Hospital of Nanjing Univer2009-01
NCT00807651 — Autologous Hematopoietic Stem Cell Transplantation for Early Onset Type 1 DiabetesPhase 2Completed40Shanghai Jiao Tong University School of Medicine2008-02
NCT01322789 — Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic PatientsPhase 1, Phase 2Unknown10University of Sao Paulo2008-09

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 Diabetes (Type 1 & 2) are recruiting right now?

2 of 14 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 Diabetes (Type 1 & 2)?

Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 14 registered studies tell you research exists, not that a product cleared review.

How advanced is the research on HSCT for Diabetes (Type 1 & 2)?

1 of 14 records carry a Phase 3 or Phase 4 label and 6 are marked completed. Registrations run from 2003 to 2025.

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.

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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.