Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAffiliated Hospital of Nantong University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ABMSC

    Biological/Vaccine

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

  • ABMSC

    Biological/Vaccine

    Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route;Low-dose group; 2.5\*10\^6 cell/dose

  • ABMSC

    Biological/Vaccine

    Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route;High-dose group; 1.0\*10\^7 cell/dose

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: Ommaya Reservoir GroupExperimental treatment 1 intervention
Group B: Low-Dose intra-arterial transplantation groupExperimental treatment 1 intervention
Group C: High-Dose intra-arterial transplantation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events and serious adverse events

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

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

Secondary outcomes

1

National Institutes of Health Stroke Scale(NIHSS) score

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

Time frame
3-7 days post each transplantation and 6-month follow-up
2

Modified Rankin Scale(mRS) score

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

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

Modified Barthel Index

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

Time frame
3-7 days post each transplantation and 6-month follow-up
4

Fugl-Meyer Assessment

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Affiliated Hospital of Nantong University

Lead sponsor

Nantong Shengyuan Stem Cell Techology Co., Ltd

Collaborator

This trial is not recruiting at the moment. You can still explore other options: