Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

NCT02564328 | Unknown Phase 1 DMC

• 1 other identifier: 201400000003-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Bone Marrow Mesenchymal Stem Cell; Transplantation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Fugl-Meyer Scale at 12 months

  1,3,6 and 12 months

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

Intravenous stem cell transplantation

ACTIVE COMPARATOR

Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation

Genetic: Intravenous stem cell transplantation

Conventional treatment

NO INTERVENTION

Control group receive conventional stroke treatment that include rehabilitation

Interventions

Intravenous stem cell transplantation GENETIC

Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation

Intravenous stem cell transplantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Medical University, China: lead
• Second Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Xiaodan Jiang

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiaodan Jiang, MD,PhD

  Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodan Jiang, MD,PhD

CONTACT

86 20 61643268; jiangxiao_dan@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhujiang Hospital,Southern Medical University, China

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: September 30, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

CN (1)