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Rapid Delivery of Autologous Bone Marrow Derived Stem Cells in Acute Myocardial Infarction Patients.

NCT01536106 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-09-04

No results posted yet for this study

Summary

The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI.

The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent placebo control patient group meeting eligibility but not receiving autologous bone marrow derived stem cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function.

Conditions

  • Acute Myocardial Infarction

Interventions

OTHER

Autologous Bone marrow mononuclear cells

Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.

OTHER

Placebo control

Intracoronary infusion of autologous peripheral blood.

Sponsors & Collaborators

  • TotipotentRX Corporation

    collaborator UNKNOWN

  • TotipotentRX Cell Therapy Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Venkatesh Ponemone, PhD · TotipotentRX Cell Therapy Pvt. Ltd.

  • Kenneth Harris, MS · TotipotentRX Cell Therapy Pvt. Ltd.

  • Ashok Seth, FRCP, FACC · Fortis Escorts Heart Institute and Research Centre

  • Upendra Kaul, MD,DM, FACC · Fortis Flt. Lt. Rajan Dhall Hospital

  • Sreenivas A Kumar, MD, DM, FACC · CARE Hospitals Hyderabad, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-01-31
Completion
2015-03-31

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 NCT01536106 on ClinicalTrials.gov