Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

NCT06752720 | Recruiting Phase 2 DMC

• 1 other identifier: R6-8
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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)

Conditions

Stroke; Stroke, Ischemic; Stroke; Sequelae

Keywords

stem cell therapy; mesenchymal stem cell; ischemic stroke; chronic

Outcome Measures

Primary Outcomes (1)

• Efficacy of HUNS001-01 administration

  The frequency of the improvement in mRS of disability by 1 or more from baseline

  one year

Secondary Outcomes (7)

• Safety of HUNS001-01 administration

  one year

• Change in NIHSS examination

  one year

• Change in FIM examination

  one year

• Change in Fugl-Myer examination

  one year

• Change in Barthal index examination

  one year

Study Arms (1)

Stem cell transplantation

EXPERIMENTAL

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

Drug: Stem cell Transplantation

Interventions

Stem cell Transplantation DRUG

Manufactured autologous mescenchymal stem cell (HUNS001-01) in our cell processing center will be injected into the brain, totally 4 x 10\^7 cells, in 2 brain sites.

Stem cell transplantation

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging
• No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)
• Subjects who can give informed consent by its self

You may not qualify if:

• 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)
• 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
• History of malignancy
• Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
• Pregnant or lactating or expecting to become pregnant during the study
• Known serious allergy to any agents used in the study
• Contraindication for magnetic resonance imaging
• History of seizure within 2 years
• 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"
• \. Any condition that in the judgement of the investigator would place the patient at undue risk

Sponsors & Collaborators

• Hokkaido University Hospital: lead
• RAINBOW Inc.: collaborator

Study Sites (1)

Hokkaido University Hospital

Sapporo, Hokkaido, 0608638, Japan

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Bronchiolitis Obliterans Syndrome

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Central Study Contacts

Kota Kurisu, M.D., Ph.D.

CONTACT

+81-11-706-1161; kkurisu0912@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)