Clinical trial NCT00883727: Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
Official title: A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarction
Keywords: mesenchymal stem cells
myocardial infarction
Lead sponsor: Stempeutics Research Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.
* Patient has global left ventricular systolic dysfunction with an ejection fraction of \<50% and \>30%.
* ECG with sign of acute anterior MI with ST-elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST-elevation ≥1 mm on all of the following leads- II, III, V5-V6 or STelevation ≥ 2 mm in at least 2 of the leads.
* The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.
* Patient with acute myocardial infarction within 10 days prior to IP administration.
* Normal liver and renal function.
* Able to understand study information provided to him.
* Able to give voluntary written consent.

Exclusion Criteria:

* History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
* Advanced renal dysfunction and creatinine ≥ 2mg%.
* Advanced hepatic dysfunction.
* Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy

Primary outcomes:
measure: AE and ECG parameters
timeFrame: 6 months
Secondary outcomes:
measure: Regional myocardial perfusion and infarct size
timeFrame: 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Care Hospital
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: SAL Hospital and Medical Institute
state: Gujarat
city: Bangalore
country: India
facility: MS Ramaiah Memorial Hospital
state: Karnataka
city: Bangalore
country: India
facility: Bhagawan Mahaveer Jain Heart Centre
state: Karnataka
Study officials:
affiliation: Care Hospital, Hyderabad
name: Sreenivas Kumar, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: SAL Hospital, Ahmedabad
name: Satya Gupta
role: PRINCIPAL_INVESTIGATOR
affiliation: Bhagwan Mahaveer JAin Hospital, Bangalore
name: R Keshava, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: MS Ramaiah Memorial Hospital, Bangalore
name: Prakash VS, MD., DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chullikana A, Majumdar AS, Gottipamula S, Krishnamurthy S, Kumar AS, Prakash VS, Gupta PK. Randomized, double-blind, phase I/II study of intravenous allogeneic mesenchymal stromal cells in acute myocardial infarction. Cytotherapy. 2015 Mar;17(3):250-61. doi: 10.1016/j.jcyt.2014.10.009. Epub 2014 Dec 4.