Clinical trial NCT06997939: Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke
Official title: A Clinical Trial of Autologous Bone Marrow-Derived Mesenchymal Stem Cell Transplantation for Precision Therapy in Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke
Keywords: autologous
bone marrow mesenchymal stem cell
mRS
functional recovery
Carotid artery intervention
NIHSS
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: Nantong Shengyuan Stem Cell Techology Co., Ltd
First posted: 2025-05-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, three-arm parallel randomized controlled trial: Group A (Ommaya reservoir delivery), Group B (low-dose intra-arterial transplantation), and Group C (High-dose intra-arterial transplantation), with double-blinding.
Primary purpose: TREATMENT

Brief summary: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Use of immunosuppressive drugs (e.g., steroids) within 3 months or vaccination within 6 months
* Any organic lesions causing increased intracranial pressure
* Current or past malignancy
* Seropositive for HIV, syphilis, hepatitis B, hepatitis C, or other severe infectious diseases
* Severe mental illness or impaired consciousness
* Coagulopathy or ongoing anticoagulant therapy
* Blood pressure ≥180/110 mmHg despite treatment
* Poorly controlled diabetes with advanced complications and Pre-existing conditions affecting limb mobility (e.g., claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis)
* Participation in another clinical trial within 3 months
* Major surgery or trauma (including fractures) within 1 month
* Any other condition deemed unsuitable for study participation by the investigator

Primary outcomes:
measure: Adverse events and serious adverse events
timeFrame: 3-7 days post each transplantation and 6-month follow-up
Secondary outcomes:
measure: National Institutes of Health Stroke Scale（NIHSS） score
timeFrame: 3-7 days post each transplantation and 6-month follow-up
measure: Modified Rankin Scale(mRS) score
timeFrame: 3-7 days post each transplantation and 6-month follow-up
measure: Modified Barthel Index
timeFrame: 3-7 days post each transplantation and 6-month follow-up
measure: Fugl-Meyer Assessment
timeFrame: 3-7 days post each transplantation and 6-month follow-up
measure: Fugl-Meyer Balance Assessment
timeFrame: 3-7 days post each transplantation and 6-month follow-up
measure: 10-Meter Walk Test(10MWT) Time
timeFrame: 3-7 days post each transplantation and 6-month follow-up
measure: Functional Ambulation Category(FAC)
timeFrame: 3-7 days post each transplantation and 6-month follow-up
measure: Cerebral infarct volume changes on MRI
timeFrame: 6-month follow-up
measure: Surface electromyography(sEMG) signal changes
timeFrame: 3-7 days post each transplantation and 6-month follow-up
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Qiuhong Ji, MD, PhD
role: STUDY_CHAIR
References: