Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06752720
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2024-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Sponsor:
Hokkaido University Hospital
Organization:
Study Overview
Official Title:
Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAINBOW-2a
Brief Summary:
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)
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: