Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

NCT00950521 | Completed Phase 2 DMC

• 2 other identifiers: DMR-96-IRB-145DOH Approval No:098004365
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.

Conditions

Stroke; Middle Cerebral Artery Infarction

Keywords

Stroke; Stem Cell; Cell Therapy; CD34 Stem cell; Peripheral blood Stem cell

Outcome Measures

Primary Outcomes (1)

• NIH-stroke scale (NIHSS)

  1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

Secondary Outcomes (4)

• European stroke scale (ESS)

  1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

• European stroke motor subscale (EMS)

  1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

• Barthel index and Mini-Mental State Examination (MMSE)

  1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

• Magnetic resonance imaging (MRI) and computed tomography (CT) scans

  1, 2, 4, 12 weeks, and confirmed at 6 and 12 months

Study Arms (2)

PBSC Treatment

ACTIVE COMPARATOR

Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication

Procedure: Intercerebral implantation of Autulogous Stem Cells

Control

ACTIVE COMPARATOR

Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication

Drug: convention therapy

Interventions

Intercerebral implantation of Autulogous Stem Cells PROCEDURE

2-8 millions Stem cell per patients plus convention therapy

Also known as: PBSC, CD34 Stem Cell

PBSC Treatment

convention therapy DRUG

antiplatelet

Control

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 35-70 chronic stroke adult patient,
• with stroke history of more than 6 months, less than 60 months，
• with stable hemiplegia condition, and
• NIHSS (NIH Stroke Scale) score is between 9-20.

You may not qualify if:

• patients aged less than 35 or more than 70,
• hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
• pregnant women,
• impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

Related Publications (1)

• Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.

  PMID: 22163120 DERIVED

MeSH Terms

Conditions

Stroke; Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Shinn-Zong Lin, MD, DMSci

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: July 31, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 21, 2011

Record last verified: 2011-04

Locations

TW (1)