NCT06752720RecruitingPhase 2
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Hokkaido University Hospital
- Diseases
- Stroke
- NCT number
- NCT06752720
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 8
- From 1 Dec 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe heart disease (ischaemic heart disease, heart failure)
- History of malignancy
- Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
- Known serious allergy to any agents used in the study
- 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"
- 14\. Any condition that in the judgement of the investigator would place the patient at undue risk
Lab values
- Anaemia (Hg \< 10·0 g/dL)
- Thrombocytopaenia (platelet count \< 100,000/mm3)
- 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
Other
- Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"
- Pregnant or lactating or expecting to become pregnant during the study
- Contraindication for magnetic resonance imaging
Who the study is looking for
- 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
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.