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Stem Cell Therapy For Acute Ischemic Stroke Patients

NCT02425670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-04-24

No results posted yet for this study

Summary

The purpose of this study is to determine whether patients with subacute ischemic stroke will benefit from infusion of patient's own bone marrow derived stem cells.

Primary Hypothesis: Intravenous injection of bone marrow mononuclear cells at a dose of 30 to 500 million in patients with subacute ischemic stroke results in reduction of infarct volume and improvement of neurological function compared to those without the injection.

Secondary Hypothesis: Patients receiving more than 100 million Bone marrow derived stem cells (BMSC) will have better outcome than those receiving fewer dosages of cells.

Conditions

  • Middle Cerebral Artery Infarction
  • Anterior Cerebral Artery Infarction

Interventions

OTHER

BMSCs

30-500 million Autologous BMSCs will be given intravenously to patients with acute ischemic stroke (onset from 7 to less than 30 days).

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • Army Hospital Research And Referral, India

    collaborator OTHER

  • Armed Forces Medical College, Pune

    collaborator OTHER

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    collaborator OTHER

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Kameshwar Prasad, MBBS, MD · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-10-31
Completion
2011-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425670 on ClinicalTrials.gov