Not yet taking people in ChinaPhase 1/2

Tests patient's own bone marrow stem cells after ischemic stroke

Tests infusions of patients' own bone marrow stem cells in adults with ischemic stroke.

Key facts

Who runs it: Affiliated Hospital of Nantong University
Where: Nantong, ChinaSee the site
Trial code: NCT06997939
Registry title: Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke
Status: Not yet recruiting
Phase: Phase 1/2
People taking part: 12 people, planned
Started: 1 Jun 2025
Expected to end: 31 May 2027
Type of study: Interventional, 3 groups
Treatments tested: ABMSC
Record updated: 31 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-65 who had an ischemic stroke 3-12 months ago and still have moderate to severe disability. They would receive stem cells from their own bone marrow.

Age: 18 to 65 years
Sex: Men and women
Disease stage: Ischemic stroke confirmed 3-12 months before enrollment; moderate stroke with NIHSS score 5-12; Modified Rankin Scale score 3-5 (moderate to severe disability).
Earlier treatment: Cannot have used immunosuppressive drugs (for example steroids) within 3 months, or been vaccinated within 6 months.

Main reasons for not taking part

Needle phobia or lumbar spine disease affecting bone marrow collection
Severe heart, liver, or kidney dysfunction
Current or past cancer
Positive for HIV, syphilis, hepatitis B, hepatitis C, or other severe infectious diseases
Coagulopathy or ongoing anticoagulant therapy

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

Age 18-65 years, both male and female
Confirmed diagnosis of ischemic stroke within 3-12 months before enrollment
Moderate stroke with NIHSS score 5-12 at screening
Modified Rankin Scale (mRS) score 3-5 (moderate to severe disability)
Patient or legal guardian willing to provide written informed consent for treatment and study participation
Able to comply with medical history collection, data storage, and follow-up procedures

Who cannot take part

Use of immunosuppressive drugs (e.g., steroids) within 3 months or vaccination within 6 months
Coagulopathy or ongoing anticoagulant therapy
Major surgery or trauma (including fractures) within 1 month
Patients with needle phobia or lumbar spine disease affecting bone marrow aspiration
Any acute illness at the time of screening
Severe disability or end-stage disease
Severe heart, liver, or kidney dysfunction
Pulmonary infection or severe systemic infection
History of severe allergic reactions
Current or past malignancy
Seropositive for HIV, syphilis, hepatitis B, hepatitis C, or other severe infectious diseases
Severe mental illness or impaired consciousness
Poorly controlled diabetes with advanced complications and Pre-existing conditions affecting limb mobility (e.g., claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis)
Any other condition deemed unsuitable for study participation by the investigator
Any organic lesions causing increased intracranial pressure
Blood pressure ≥180/110 mmHg despite treatment
Participation in another clinical trial within 3 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 65 years old?

Where in China

Affiliated Hospital of Nantong UniversityNantong, ChinaContact: Qiuhong Ji, MD, PhDNo longer taking part

About the trial

What the trial wants to find out

Stroke is a group of diseases mainly characterized by cerebral ischemia or hemorrhage, with a high fatality rate and disability rate. It has now become a major obstacle to social and economic development. Stem cells are a type of primitive cells with self-renewal, proliferation and differentiation potential. Under certain conditions, they can differentiate into cells of various tissues and organs. They have now become one of the key research directions for the repair of functional disorders after ischemic stroke. Compared with other types of stem cells, bone marrow mesenchymal stem cells (BMSCs) have the advantages of being relatively easy to obtain with less tissue damage, convenient and rapid in vitro expansion and culture, and the ability to actively migrate to the lesion area after injection without the risk of canceration.

Read full original descriptionShow less

This study plans to recruit and screen 12 subjects with ischemic stroke, divided into three groups (Ommaya drug reservoir group, low-dose internal carotid artery transplantation group, and high-dose internal carotid artery transplantation group), with 4 subjects in each group, for a clinical study of ABMSCs treatment for functional disorders after ischemic stroke. In accordance with the established treatment protocol, bone marrow will be collected from subjects during the stable phase of their condition, and ABMSCs will be infused three times via Ommaya drug reservoir/internal carotid artery within 1-6 months after collection. The study will assess the improvement of motor function in patients and analyze the feasibility and effectiveness of this therapy, laying a solid foundation for future clinical applications.

The 3 groups in the trial

Ommaya Reservoir GroupTreatment being tested
Stem Cell via Ommaya；2\*10\^7 cells dose
Treatment: ABMSC
Low-Dose intra-arterial transplantation groupTreatment being tested
Internal carotid artery(ICA) transplantation；Low-dose; 2.5\*10\^6 cells dose
Treatment: ABMSC
High-Dose intra-arterial transplantation groupTreatment being tested
Internal carotid artery(ICA) transplantation；High-dose; 1.0\*10\^7 cells dose
Treatment: ABMSC