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NCT06752720: RAINBOW-2a
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Phase 2 trial testing Stem cell Transplantation in Stroke in 8 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Hokkaido University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 1 December 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 30 November 2027 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Stem cell Transplantation — full drug profile →
Conditions studied
- Stroke — all drugs for Stroke →
- Stroke, Ischemic — all drugs for Stroke, Ischemic →
- Stroke; Sequelae — all drugs for Stroke; Sequelae →
Sponsor
Hokkaido University Hospital
Who can join
Adults 20 to 70, any sex, with Stroke or Stroke, Ischemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are: Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention? Participants will receive the below interventions. * Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging) * Harvest of platelet concentrates (PC) * Harvest of bone marrows (BM) * Receive intracerebral transplantation surgery of HUNS001-01 * Post-operative rehabilitation * Follow-up studies (until 1 year or termination of the trial)
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mesenchymal stem cells and the central nervous system: historical perspectives and future directions.
Mazurek CY, Kaniuk JK, Ahuja CS. · · 2026 · PMID 41809632 · DOI 10.3389/fnmol.2026.1742864 -
Cell therapy for stroke and spinal cord injury in clinical trials.
Fan Y, Wong ST, Goh ELK, Chan JKY. · · 2026 · PMID 41641797 · DOI 10.1093/stcltm/szaf082
Verify or expand the search:
- PubMed search for NCT06752720
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Hokkaido University Hospital trials
Trials by the same sponsor.
- NCT05252429 — Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06752720 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hokkaido University Hospital
- Last refreshed: 24 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06752720.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing