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Stem Cell Implantation in Patients Undergoing CABG

NCT01721902 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2013-12-04

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate the feasibility and safety of intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow stem cells will be assessed.

The investigators hypothesize that collection of a sufficient number of CD133+ cells through bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial injection of high purity cells following completion of CABG, will be feasible without significant adverse clinical consequences.

Conditions

Interventions

DEVICE

Autologous CD133+ Bone Marrow Stem Cells

Intra-myocardial injection of 2-3 x 10E6 CD133+ Bone Marrow Stem Cells

OTHER

Carrier Solution

Intra-myocardial injection of carrier solution

Sponsors & Collaborators

  • Miltenyi Biotec, Inc.

    lead INDUSTRY

Principal Investigators

  • Yi-Ping J Woo, M.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01721902 on ClinicalTrials.gov