Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02564328

Enrollment

Registered

2015-09-30

Start date

2014-11-30

Completion date

2017-11-30

Last updated

2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Bone Marrow Mesenchymal Stem Cell, Transplantation

Brief summary

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.

Detailed 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.

Interventions

GENETICIntravenous stem cell transplantation

Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in Fugl-Meyer Scale at 12 months	1,3,6 and 12 months

Secondary

Measure	Time frame
Change from baseline in mRS at 12 months	1,3,6 and 12 months
Improvement of vision measured by brain visual examination	1,6 and 12 months
Change from baseline in NIH Stroke Scale at 12 months	1,3,6 and 12 months
Change from baseline in Barthel Index at 12 months	1,3,6 and 12 months
Change from baseline in SSS at 12 months	1,3,6 and 12 months

Countries

China

Contacts

Primary ContactXiaodan Jiang, MD,PhD

jiangxiao_dan@163.com86 20 61643268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026