Study of Homing of Labelled Stem Cells in Human Heart. (COLT)

June 6, 2014 updated by: Dr Sandeep Seth, All India Institute of Medical Sciences, New Delhi

Labelling of Stem Cells With Technetium 99- m Hexamethylene Propylene Amine Oxide ( Tc99m HMPAO)to Monitor Homing in the Human Heart. Bench to Bedside Studies [ COLT -- COronary Labelling Trial ]

One of the challenges of stem cell therapy is to understand the fate of the injected stem cell. By labelling various stem cells with radioisotopes their fate (homing) can be demonstrated. In this study, we will develop and refine the existing techniques of stem cell labelling to various subtypes of stem cells namely- freshly aspirated bone marrow cells, cryopreserved bone marrow cells, g-csf mobilized peripheral blood stem cells and umbilical cord cells. After testing the labelling efficacy and viability, these cells will be injected in to the coronary arteries of patients with myocardial infarction who have undergone a successful revascularization either by angioplasty or thrombolysis. Homing of stem cells will be demonstrated by nuclear scan after the procedure. We are adapting techniques used to label cells for detection of infection and bleeding using nuclear scans for in vivo scanning. Also we are using Technetium instead of FDG which has very little radioactivity allowing us to work with the current cardiac labs with out having to reconstruct the labs with special shielding for radioactive compounds. Real benefit of stem cells then can be explored after demonstrating the proper homing.

Study Overview

Status

Unknown

Conditions

Detailed Description

Phase One: Four Different types of stem cells will be tested ( Freshly aspirated Bone marrow cells, cryopreserved cells, umbilical cord cells, Stem cells mobilised from bone marrow by g-csf, mesenchymal cells), and the efficacy of labelling documented and effect on viability noted. 3 samples of each type will be tested and the results will be documented. Different cells are being tried to test the efficiency of the labelling technique in different types of cells. This will provide the protocols for all future labelling studies. This will be conducted in collaboration between the stem cell department, nuclear medicine department and nuclear cardiology department.

Phase Two (Clinical Study):

This will be the pilot clinical study done alongside with the phase one study, and will enrol 10 patients with Recent Myocardial infarction ( within 3 months) . A small fraction of patient's own bone marrow stem cells will be labelled with Technetium 99m HMPAO. The labelled cells will be administered via the intracoronary injection along with the unlabeled stem cells. The localization of the radio-labelled stem cells in the myocardium will then be detected using the conventional Gamma camera.

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients within 3 months following myocardial infarction

Description

Inclusion Criteria:

  • Myocardial Infarction (< Three Months) with either angioplasty or thrombolysis done to open the infarct causing artery.
  • Patent coronary arteries after the infarct
  • Left ventricular dysfunction (ejection fraction < 50%)

Exclusion Criteria:

  • Ongoing infection
  • Obstructive coronary disease
  • History of symptoms more than 3 months
  • Any evidence of malignancy or other systemic illness.
  • Cell yield less than 10 million cells

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
experimental : intracoronary stem cells
intracoronary stem cells will be injected in infarct related artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
homing of labelled cells to infarct zone and scan showing radioactivity in the infarct area
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Collaborators

Indian Council of Medical Research

Investigators

  • Study Chair: Neeraj Parakh, DM, All India Institute of Medical Sciences, New Delhi
  • Study Chair: Chetan Patel, All India Institute of Medical Sciences, New Delhi
  • Study Chair: Sujata Mohanty, All India Institute of Medical Sciences, New Delhi
  • Study Chair: Sneh Lata, All India Institute of Medical Sciences, New Delhi
  • Study Chair: Balram Bhargava, DM, All India Institute of Medical Sciences, New Delhi
  • Study Chair: Vinay Kr Bahl, DM, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (ESTIMATE)

May 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICMR 80/1/2014- BMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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