Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke

NCT06997939 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025-G097
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

autologous; bone marrow mesenchymal stem cell; mRS; functional recovery; Carotid artery intervention; NIHSS

Outcome Measures

Primary Outcomes (1)

• Adverse events and serious adverse events

  To assess safety, the number of AEs or SAEs will be evaluated

  3-7 days post each transplantation and 6-month follow-up

Secondary Outcomes (9)

• National Institutes of Health Stroke Scale（NIHSS） score

  3-7 days post each transplantation and 6-month follow-up

• Modified Rankin Scale(mRS) score

  3-7 days post each transplantation and 6-month follow-up

• Modified Barthel Index

  3-7 days post each transplantation and 6-month follow-up

• Fugl-Meyer Assessment

  3-7 days post each transplantation and 6-month follow-up

• Fugl-Meyer Balance Assessment

  3-7 days post each transplantation and 6-month follow-up

Study Arms (3)

Ommaya Reservoir Group

EXPERIMENTAL

Stem Cell via Ommaya；2\*10\^7 cells dose

Biological: ABMSC

Low-Dose intra-arterial transplantation group

EXPERIMENTAL

Internal carotid artery(ICA) transplantation；Low-dose; 2.5\*10\^6 cells dose

Biological: ABMSC

High-Dose intra-arterial transplantation group

EXPERIMENTAL

Internal carotid artery(ICA) transplantation；High-dose; 1.0\*10\^7 cells dose

Biological: ABMSC

Interventions

ABMSC BIOLOGICAL

Autologous bone marrow-derived mesenchymal stem cells administered via Ommaya reservoir；2.0\*10\^7 cell/dose

Ommaya Reservoir Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead
• Nantong Shengyuan Stem Cell Techology Co., Ltd: collaborator

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qiuhong Ji, MD, PhD

  Affiliated Hospital of Nantong University

  STUDY CHAIR

Central Study Contacts

Qiuhong Ji, MD, PhD

CONTACT

+8613962916293; jiqiuhong@ntu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind design: Participants and investigators are masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 31, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)