Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

Stroke Clinical Trial

Official title:

Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01714167
• Other study ID #: WZMC-2011-8
• Status: Recruiting
• Phase: Phase 1
• First received: October 19, 2012
• Last updated: June 4, 2015
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Wenzhou Medical University
• Contact: Qichuan Zhuge, M.D.
• Email: zhugeqichuan[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Description:

For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. 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 stroke. The neurological outcome will be determined after transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 40-70 ischemia stroke or intracerebral hemorrhage patient

• With stroke history of more than 3 months, less than 60 months

• With stable hemiplegia condition

• NIHSS (NIH stroke scale) score of 7 or more points

• Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria:

• Patients aged less than 40 or more than 70

• Lacunar infarction

• History of neurological disease, head injury or psychiatric disorder with disablity

• Pregnant women

• Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition

• Inaccessibility for follow up

• Unwillingness to provide written informed consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Genetic:
• intracerebral stem cell transplantation
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Wenzhou Medical University	University of North Texas Health Science Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in NIH Stroke Scale at 12 months		1, 6 and 12 months	Yes
Secondary	Improvement of infarct size measured by brain MRI		1,6 and 12 months after transplantation	No