Study of Homing of Labelled Stem Cells in Human Heart. (COLT)
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|ClinicalTrials.gov Identifier: NCT02148666|
Recruitment Status : Unknown
Verified June 2014 by Dr Sandeep Seth, All India Institute of Medical Sciences, New Delhi.
Recruitment status was: Not yet recruiting
First Posted : May 28, 2014
Last Update Posted : June 9, 2014
|Condition or disease|
|Homing of Stem Cells in the Infarct Area.|
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|
|Estimated Enrollment :||10 participants|
|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 ]|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||December 2017|
experimental : intracoronary stem cells
intracoronary stem cells will be injected in infarct related artery.
- homing of labelled cells to infarct zone and scan showing radioactivity in the infarct area [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148666
|Contact: Sandeep Seth, DM||91-11-26598850 ext email@example.com|
|Contact: Sandeep Seth, DMfirstname.lastname@example.org|
|All India Institute of Medical Sciences||Not yet recruiting|
|New Delhi, Delhi, India, 110029|
|Contact: Sandeep Seth, DM 91-11-26594970 ext 4970 email@example.com|
|Contact: S Seth, Dm firstname.lastname@example.org|
|Principal Investigator: Sandeep Seth, DM|
|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|