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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Sandeep Seth, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT02148666
First received: May 23, 2014
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition
Homing of Stem Cells in the Infarct Area.

Study Type: Observational
Official Title: 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 ]

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • homing of labelled cells to infarct zone and scan showing radioactivity in the infarct area [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
experimental : intracoronary stem cells
intracoronary stem cells will be injected in infarct related artery.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients within 3 months following myocardial infarction

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02148666

Contacts
Contact: Sandeep Seth, DM 91-11-26598850 ext 4970 drsandeepseth@hotmail.com
Contact: Sandeep Seth, DM 09-11-26594970 aiimscardiology@yahoo.co.in

Locations
India
All India Institute of Medical Sciences Not yet recruiting
New Delhi, Delhi, India, 110029
Contact: Sandeep Seth, DM    91-11-26594970 ext 4970    drsandeepseth@hotmail.com   
Contact: S Seth, Dm       aiimscardiology@yahoo.co.in   
Principal Investigator: Sandeep Seth, DM         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Indian Council of Medical Research
Investigators
Principal Investigator: Sandeep Seth, DM All India Institute of Medical Sciences, New Delhi
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
Study Chair: Balram Airan, DM All India Institute of Medical Sciences, New Delhi