Stem cell therapy for chronic stroke recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of autologous mesenchymal stem cell transplantation (HUNS001-01) in promoting neurological recovery in patients suffering from chronic ischemic stroke with moderate to severe symptoms. Participants will undergo a series of procedures including screening, harvesting of bone marrow and platelet concentrates, and intracerebral transplantation surgery, followed by rehabilitation and follow-up assessments for one year. The primary goals are to determine if this therapy can improve disability scores and to assess safety over the study period.

Why it matters

Who can join: the full rules

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"

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

Where it's running

• Hokkaido University Hospital
  Sapporo, Hokkaido, Japan Recruiting

Study contacts

• Study coordinator: Kota Kurisu, M.D., Ph.D.
• Email: kkurisu0912@gmail.com
• Phone: +81-11-706-1161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

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• NeuroAiD test in mild to moderate ischemic stroke patients

  This study tests whether adding MLC901 (NeuroAiD II) to standard stroke care helps adults who recently had an ischemic stroke recover better than standard care alone.

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• Using IMPROVE to guide carotid revascularisation decisions

  This trial tests whether using the IMPROVE MRI-based score to select patients for carotid revascularisation is as good as standard care based mainly on stenosis degree, among people who have had a recent stroke or TIA due to carotid disease.

  Recruiting Maastricht University Medical Center · Arnhem, Gelderland and 9 other locations · NCT07556887

• Vojta therapy to improve posture and trunk control after stroke

  This study will see if adding Vojta reflex locomotion therapy to routine physical therapy helps adults with recent ischemic stroke improve posture, trunk control, and arm movement.

  Recruiting University of Lahore · Lahore · NCT07244952

• Robotic balance training with brain stimulation to improve balance after stroke

  This program tests whether adding noninvasive brain stimulation to robotic balance training helps people with chronic stroke who still have balance and walking problems.

  Recruiting Kessler Foundation · West Orange, New Jersey · NCT07113041

• Examining brain blood flow in stroke patients with motor dysfunction

  This study is testing how blood flow in the brain relates to movement problems in stroke patients to see if it can help us understand their recovery better.

  Recruiting Skolkovo Institute of Science and Technology · Moscow and 1 other locations · NCT06806397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.