COLT
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 ]
Sponsor study identifier
observational
10
1 country
1
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2014
Actual (reported)May 28, 2014
Actual (reported)August 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
homing of labelled cells to infarct zone and scan showing radioactivity in the infarct area
1 day
intracoronary stem cells will be injected in infarct related artery.
patients within 3 months following myocardial infarction
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Huikuri HV, Kervinen K, Niemela M, Ylitalo K, Saily M, Koistinen P, Savolainen ER, Ukkonen H, Pietila M, Airaksinen JK, Knuuti J, Makikallio TH; FINCELL Investigators. Effects of intracoronary injection of mononuclear bone marrow cells on left ventricular function, arrhythmia risk profile, and restenosis after thrombolytic therapy of acute myocardial infarction. Eur Heart J. 2008 Nov;29(22):2723-32. doi: 10.1093/eurheartj/ehn436. Epub 2008 Oct 9.
Kraitchman DL, Tatsumi M, Gilson WD, Ishimori T, Kedziorek D, Walczak P, Segars WP, Chen HH, Fritzges D, Izbudak I, Young RG, Marcelino M, Pittenger MF, Solaiyappan M, Boston RC, Tsui BM, Wahl RL, Bulte JW. Dynamic imaging of allogeneic mesenchymal stem cells trafficking to myocardial infarction. Circulation. 2005 Sep 6;112(10):1451-61. doi: 10.1161/CIRCULATIONAHA.105.537480. Epub 2005 Aug 29.
Sandeep Seth, DM
All India Institute of Medical Sciences
Neeraj Parakh, DM
All India Institute of Medical Sciences
Chetan Patel
All India Institute of Medical Sciences
Sujata Mohanty
All India Institute of Medical Sciences
First Submitted
May 23, 2014
First Posted
May 28, 2014
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Estimated (date passed)Contact the study team to confirm eligibility.
Kang WJ, Kang HJ, Kim HS, Chung JK, Lee MC, Lee DS. Tissue distribution of 18F-FDG-labeled peripheral hematopoietic stem cells after intracoronary administration in patients with myocardial infarction. J Nucl Med. 2006 Aug;47(8):1295-301.
Sneh Lata
All India Institute of Medical Sciences
Balram Bhargava, DM
All India Institute of Medical Sciences
Vinay Kr Bahl, DM
All India Institute of Medical Sciences
Balram Airan, DM
All India Institute of Medical Sciences
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 9, 2014
Record last verified: 2014-06
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