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Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke

NCT01501773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-12-29

No results posted yet for this study

Summary

A multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This phase of study is visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for autologous stem cell therapy in patient with acute ischamic stroke.

Conditions

  • Acute Stroke

Interventions

BIOLOGICAL

Autologous bone marrow stem cell

Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • Manipal Acunova Ltd.

    lead NETWORK

Principal Investigators

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

  • Dr. Usha Kant Misra, MBBS, MD, DM · Sanjay Gandhi Postgraduate Institute of Medical Sciences

  • Dr. R.S Sarkar · Armed Forces Medical College

  • Dr. Sudesh Kumar Prabhakar, MBBS, MD, DM · Post Graduate Institute of Medical Education and Research, Chandigarh

  • Dr. Sharat Joshi, MBBS,MD, DM · Army R & R Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT01501773 on ClinicalTrials.gov