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Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

S

Southern Medical University

Status and phase

Unknown
Phase 1

Conditions

Stroke

Treatments

Genetic: Intravenous stem cell transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02564328
201400000003-2

Details and patient eligibility

About

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Full description

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged 18-80 chronic ischemia stroke or patients
  • With stroke history of more than 6 months, less than 60 months
  • NIHSS (NIH stroke scale) score of 7 or more points
  • Internal carotid artery territory infarction measured by MRI
  • Can be hospitalized and signed informed consent
  • With fewer effect by traditional post-stroke treatments or rehabilitations

Exclusion criteria

  • Lacunar infarction
  • Recurrent thrombotic diseases less than 6 months
  • Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
  • Pregnant women
  • Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
  • Penicillin anaphylaxis or some other drugs allergy
  • Autoimmune disease
  • Inaccessibility for follow up

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Intravenous stem cell transplantation
Active Comparator group
Description:
Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation
Treatment:
Genetic: Intravenous stem cell transplantation
Conventional treatment
No Intervention group
Description:
Control group receive conventional stroke treatment that include rehabilitation

Trial contacts and locations

1

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Central trial contact

Xiaodan Jiang, MD,PhD

Data sourced from clinicaltrials.gov

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