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New treatment option for Stroke
Official title Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
ClinicalTrials.gov ID: NCT06752720
What this study is testing
What is Stem cell Transplantation?
Stem cell Transplantation is an investigational medicine, being studied as a potential treatment for stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 70
You may be able to join 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
- people with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging
You likely can't join 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...
- History of malignancy
See the full eligibility criteria
- 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
- people 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)
- people who can give informed consent by its self
- 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" 14\. Any condition that...
The study team makes the final eligibility decision.
Where it's taking place
- Sapporo, Hokkaido, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sapporo, Hokkaido, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.