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NCT06752720: RAINBOW-2a

Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

Recruiting now Phase 2 Last updated 24 January 2025
What this trial tests

Phase 2 trial testing Stem cell Transplantation in Stroke in 8 participants. Currently enrolling.

Timeline
1 December 2024
Primary endpoint
31 December 2025
30 November 2027

Quick facts

Lead sponsorHokkaido University Hospital
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment8
Start date1 December 2024
Primary completion31 December 2025
Estimated completion30 November 2027
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Stroke

Currently open trials in the same condition.

Other Hokkaido University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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