NCT01536106

Brief Summary

The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

July 16, 2011

Last Update Submit

September 3, 2013

Conditions

Acute Myocardial Infarction

Keywords

Cell therapy, Bone marrow stem cells, cardiac cell therapy

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events as a measure of safety

    Feasibility and safety of Intracoronary infusion of autologous BMMNCs processed through intraoperative point of care technology, freedom from arrhythmia's.

    12 Months

Secondary Outcomes (3)

  • Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities.

    12 Months

  • Major adverse cardiac events (MACE)

    12 Months

  • Quality of life

    12 Months

Study Arms (2)

Treatment

EXPERIMENTAL

Implantation of bone marrow derived mononuclear cells

Other: Autologous Bone marrow mononuclear cells

Placebo Control

PLACEBO COMPARATOR

Infusion of autologous peripheral blood

Other: Placebo control

Interventions

Autologous Bone marrow mononuclear cellsOTHER

Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.

Also known as: BMMNC treatment group
Treatment
Placebo controlOTHER

Intracoronary infusion of autologous peripheral blood.

Also known as: Placebo control group
Placebo Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female of age 18 - 75 years
  • 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

You may not qualify if:

  • Multi-vessel coronary disease requiring surgical intervention (CABG) or left main coronary artery disease \> 50% blockage
  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CARE Hospitals, Banjara Hills

Hyderabad, Hyderabad, 500034, India

Location

Fortis Escorts Heart Institute and Research Centre

New Delhi, New Delhi, 110025, India

Location

Fortis Flt. Lt. Rajan Dhall Hospital

New Delhi, New Delhi, 110070, India

Location

Related Publications (3)

  • 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.

    PMID: 21127322RESULT

  • 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.

    PMID: 20576835RESULT

  • 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.

    PMID: 18598362RESULT

Study Officials

  • Venkatesh Ponemone, PhD

    TotipotentRX Cell Therapy Pvt. Ltd.

    STUDY DIRECTOR

  • Kenneth Harris, MS

    TotipotentRX Cell Therapy Pvt. Ltd.

    STUDY CHAIR

  • Ashok Seth, FRCP, FACC

    Fortis Escorts Heart Institute and Research Centre

    PRINCIPAL INVESTIGATOR

  • Upendra Kaul, MD,DM, FACC

    Fortis Flt. Lt. Rajan Dhall Hospital

    PRINCIPAL INVESTIGATOR

  • Sreenivas A Kumar, MD, DM, FACC

    CARE Hospitals Hyderabad, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Harris, MS

CONTACT

13234207766ken.harris@totipotentrx.com

Venkatesh Ponemone, PhD

CONTACT

911244976860ponemone@totipotentrx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2011

First Posted

February 20, 2012

Study Start

December 1, 2013

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

IN(3)