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

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

Treatments tested in this trial

  • ABMSC
  • ABMSC
  • ABMSC

Treatment groups

12 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Affiliated Hospital of Nantong University

Lead sponsor

Nantong Shengyuan Stem Cell Techology Co., Ltd

Collaborator