Administration of autologous cranial bone derived mesenchymal stem cells for cerebral infarctio

Phase 1

Suspended

• Conditions: Moderate cerebral infarction of unilateral hemisphere including middle cerebral artery territory; Cerebrovascular disease, cerebral infarction

• Registration Number: JPRN-jRCTb060190041
• Lead Sponsor: Mitsuhara Takafumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-19
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Inclusion criteria at the time of first registration
1. First unilateral cerebral hemisphere infarction including the territory of middle cerebral artery
2. Cerebral infarction diagnosed by MRI (or CT), MRA (or CTA, cerebral angiography), electrocardiogram, chest lesion examination, etc.
3. Male or female between aged 20 or older and aged 85 or younger with 0 or 1 in modified Rankin Scale (mRS) before the onset
4. National Institutes of Health stroke scale (NIHSS) score >= 15
5. Decrease in the level of consciousness to a score of 1 or greater on item 1a of the NIHSS
6. Signs on CT of an infarct of at least 50% of the MCA territory, with or without additional infarction in the territory of the anterior or posterior cerebral artery on the same side, or
infarct volume >145 cm3 as shown on diffusion weighted MRI
7. Written informed consent by the patient or a legal representative after thorough understanding after having received sufficient explanation about this clinical study

Inclusion criteria at the time of Secondary registration
1. Informed consent by the patient or a legal representative from a free will after through understanding of this clinical study and sufficient understanding before cell transplantation

Exclusion Criteria

Exclusion criteria at the time of first registrations
1. Out of standard treatment course in initial treatment of cerebral infarction until surgical decompression (severe hemorrhagic transformation of ischemic lesion, etc.)
2. Other serious illness with contraindication for surgical decompression
3. Positivity for hepatitis B virus, hepatitis C virus, HIV, or human T-cell lymphotropic virus type 1 at the initial screening
4. Significant risk for recurrence of cerebral infarction
5. Active or unstable intracranial lesions such as moyamoya disease, cerebral aneurysms at high risk of causing rupture or embolism, and severe intracranial hemorrhage.
6. Other serious comorbidity that could affect outcome (presence of a malignant tumor, uncontrolled proliferative diabetic retinopathy, etc.)
7. Serious allergy to any possible residues in the test product (e.g. any biomaterials used in manufacturing process, and gentamicin sulfate) or any agents used for the administration of the test product or any inspections during the trial
8. Significant abnormal laboratory tests (severe medical complications such as kidney dysfunction, liver dysfunction, etc.)
9. Participate in other clinical trial
10. Pregnant or possibly pregnant, lactating women, fertile women who are unable to practice contraception
11. Improper on the basis of the judgement by primary investigator or other investigators

Secondary registration selection exclusion criteria
1. Deep coma or coma evaluated by Japan Coma Scale (JCS; 300 or 200)
2. Out of the standard course of treatment for preceding cerebral infarction
3. There is a prospect that Autologous cranial bone derived mesenchymal stem cells that do not meet shipping criteria in post-production quality inspection not available
4. Improper on the basis of the judgement by primary investigator or other investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety

Secondary Outcome Measures

Name	Time	Method
effectiveness