Rapid Delivery of Autologous Bone Marrow Derived Stem Cells in Acute Myocardial Infarction Patients.
NCT ID: NCT01536106
Last Updated: 2013-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2013-12-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent placebo control patient group meeting eligibility but not receiving autologous bone marrow derived stem cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study is a double blind, placebo controlled, randomized, multicenter trial. Male or female patients between 18-75 years with first incidence of Acute Myocardial Infarction(AMI) and LVEF less than or equal to 40% are included in the study. Patients who have undergone successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow are eligible to take part in the study.
A total of 30 subjects will be recruited and randomly assigned to receive concentrated BMMNC or placebo. All patients will undergo bone marrow aspiration within 3-10 days from the index event(infarction). Bone Marrow(BM) will be processed utilizing point of care technology. Following cell processing, the concentrated BMMNC or placebo control is infused directly into the infarct related artery using the stop flow method. Clinical follow up for all the subjects at 1,30, 60, 90, 180 and 360 days will be performed from the day of the procedure, with primary and secondary end points evaluated for both study arms.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Implantation of bone marrow derived mononuclear cells
Autologous Bone marrow mononuclear cells
Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.
Placebo Control
Infusion of autologous peripheral blood
Placebo control
Intracoronary infusion of autologous peripheral blood.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autologous Bone marrow mononuclear cells
Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.
Placebo control
Intracoronary infusion of autologous peripheral blood.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Incidence of first myocardial infarction
* Acute STEMI with LV hypokinesia involving anteroseptal, lateral or inferior walls
* LVEF \< 40% pre-intervention
* Successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow.
* Written informed consent
Exclusion Criteria
* Previous history of CABG
* Pulmonary edema
* Cardiogenic shock
* Myocarditis
* Renal or hepatic dysfunction
* Hematologic disease
* Alcohol or drug dependency, active or uncontrolled acute myocarditis
* HIV, HBV, or HCV infections
* Evidence of malignant or hematological diseases
* Metal implants of any kind
* Claustrophobia
* Renal insufficiency
* History of bleeding disorder
* Anemia (haemoglobin \<8.5mg/dl)
* Platelet count \<100,000/ml
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TotipotentRX Corporation
UNKNOWN
TotipotentRX Cell Therapy Pvt. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Venkatesh Ponemone, PhD
Role: STUDY_DIRECTOR
TotipotentRX Cell Therapy Pvt. Ltd.
Kenneth Harris, MS
Role: STUDY_CHAIR
TotipotentRX Cell Therapy Pvt. Ltd.
Ashok Seth, FRCP, FACC
Role: PRINCIPAL_INVESTIGATOR
Fortis Escorts Heart Institute and Research Centre
Upendra Kaul, MD,DM, FACC
Role: PRINCIPAL_INVESTIGATOR
Fortis Flt. Lt. Rajan Dhall Hospital
Sreenivas A Kumar, MD, DM, FACC
Role: PRINCIPAL_INVESTIGATOR
CARE Hospitals Hyderabad, India
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CARE Hospitals, Banjara Hills
Hyderabad, Hyderabad, India
Fortis Escorts Heart Institute and Research Centre
New Delhi, New Delhi, India
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, New Delhi, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sreenivas A Kumar
Role: primary
Ashok Seth, FRCS, FSCAI
Role: primary
Vinay Sanghi, MD
Role: backup
Upendra Kaul, MD
Role: primary
Tapan Ghose, MD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.
Strauer BE, Yousef M, Schannwell CM. The acute and long-term effects of intracoronary Stem cell Transplantation in 191 patients with chronic heARt failure: the STAR-heart study. Eur J Heart Fail. 2010 Jul;12(7):721-9. doi: 10.1093/eurjhf/hfq095.
Dohmann HF, Silva SA, Sousa AL, Braga AM, Branco RV, Haddad AF, Oliveira MA, Moreira RC, Tuche FA, Peixoto CM, Tura BR, Borojevic R, Ribeiro JP, Nicolau JC, Nobrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study. Trials. 2008 Jul 3;9:41. doi: 10.1186/1745-6215-9-41.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TPRX/POC/BMSC/AMIRST/1.0
Identifier Type: -
Identifier Source: org_study_id