Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients (RAINBOW-2a)

Hokkaido University Hospital

Status and phase: Enrolling; Phase 2

Conditions: Stroke; Sequelae; Stroke; Stroke, Ischemic

Treatments: Drug: Stem cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06752720

R6-8

Details and patient eligibility

About

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)

Enrollment: 8 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Age between 20 and 70 years
2. Clinical diagnosis of ischemic stroke between 6 months and 5 years ago
3. Ischemic area in the territory of unilateral interanal cerebral artery
4. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
5. Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging
6. No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)
7. Subjects who can give informed consent by its self

Exclusion criteria

1. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"

2. Anaemia (Hg < 10·0 g/dL)

3. Thrombocytopaenia (platelet count < 100,000/mm3)

4. Severe heart disease (ischaemic heart disease, heart failure)

5. Severe Systemic organ failure ALT <3·0× upper limit of normal Total bilirubin < 1·5× upper limit of normal Serum creatinine < 1·5× upper limit of normal

6. History of malignancy

7. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19

8. Pregnant or lactating or expecting to become pregnant during the study

9. Known serious allergy to any agents used in the study

10. Contraindication for magnetic resonance imaging

11. History of seizure within 2 years

12. Subject's body weight less than 45 kg for male and 40kg for female "13. Participating in another clinical trial within 90 days, or planning to participate in another clinical trial in the future"

13. Any condition that in the judgement of the investigator would place the patient at undue risk

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Stem cell transplantation

Experimental group

Description:

Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10\^7 MSC cells)

Treatment:

Drug: Stem cell Transplantation