Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-70
SponsorHokkaido University Hospital
About this trial
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)
Eligibility criteria
Qualifiers
Age between 20 and 70 years
Clinical diagnosis of ischemic stroke between 6 months and 5 years ago
Ischemic area in the territory of unilateral interanal cerebral artery
Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
Disqualifiers
Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"
Anaemia (Hg < 10·0 g/dL)
Thrombocytopaenia (platelet count < 100,000/mm3)
Severe heart disease (ischaemic heart disease, heart failure)
Trial design
Treatments tested in this trial
- Stem cell Transplantation
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Hokkaido University Hospital
Lead sponsor
RAINBOW Inc.
Collaborator
Source ClinicalTrials.gov