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NCT Number: NCT06997939

Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABMSC

Biological

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

Primary outcomes

  1. Adverse events and serious adverse events

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

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

Secondary outcomes

  1. National Institutes of Health Stroke Scale（NIHSS） score

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

    The changes during the treatment and observation period and follow-up period compared with those before treatment

  2. Modified Rankin Scale(mRS) score

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

    The changes during the treatment, observation period and follow-up period compared with those before treatment

  3. Modified Barthel Index

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

    The changes during the treatment, observation period and follow-up period compared with those before treatment

  4. Fugl-Meyer Assessment

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

    The changes during the treatment, observation period and follow-up period compared with those before treatment

  5. Fugl-Meyer Balance Assessment

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

    The changes during the treatment, observation period and follow-up period compared with those before treatment

  6. 10-Meter Walk Test(10MWT) Time

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

    The changes during the treatment, observation period and follow-up period compared with those before treatment

  7. Functional Ambulation Category(FAC)

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

    The changes during the treatment, observation period and follow-up period compared with those before treatment

  8. Cerebral infarct volume changes on MRI

    Time frame: 6-month follow-up

    The changes during the follow-up period compared with those before treatment

  9. Surface electromyography(sEMG) signal changes

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

    The changes during the treatment, observation period and follow-up period compared with those before treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Qiuhong Ji, MD, PhD

CONTACT

[email protected]

+8613962916293

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Collaborators

  • Nantong Shengyuan Stem Cell Techology Co., Ltd

Registry information

Official study title

A Clinical Trial of Autologous Bone Marrow-Derived Mesenchymal Stem Cell Transplantation for Precision Therapy in Ischemic Stroke

Acronym: ABMSC-IS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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