NCT00523224

Brief Summary

Study title: A Study of Combined Coronary Artery Bypass Grafting (CABG) and Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Congestive Heart Failure due to Ischemic Heart Disease (ACPs-CHF) Principle Investigator: Kit V. Arom ,M.D.,Ph.D. Deputy Director, Chief Cardio-Thoracic Surgeon, Bangkok Heart Hospital Study objective : To determine the safety and efficacy of injection of blood-borne autologous ACPs into the non-graftable area of the heart of patients with congestive heart failure due to ischemic heart disease Its main goal is evaluation of feasibility and safety of the combined technique. The efficacy of the treatment will be tested in the following trial. Study Design : Phase I , a single center, a non-randomized, open-label trial to test the safety, of intramyocardium transepicardium administration of ex vivo expanded autologous ACPs administered in combination with CABG operation in patients with congestive heart failure due to ischemic heart disease. The study is a preliminary training study, under the supervision of the experienced Dr. Patel the U.S. principal investigator. Study population : Total expected no. of patients : 5 main selection criteria :

  1. 1.Patients with or without signs of congestive heart failure due to ischemic heart disease who had maximal medical treatments. Not suitable to percutaneous intervention
  2. 2.All patients must have a recent coronary angiogram. Patients must be able to have OPCAB and then have Angiogenic Cell Precursors(ACPs) in non-graftable and/or infraction regions
  3. 3.Age 18 to 80 years
  4. 4.MRI demonstrating areas of viable and non-viable myocardium Investigational Product : The patients will be blood drawn 250 ml at D-8 for producting autologous ACPs (VescellTM), On D0 ,at least 1.5 million ACPs with viability \>75 % supended in 15 ml sterile cell culture medium will be injected 1 cm apart using a 23 gauge angled needle in 30 spots (0.5 ml /point) to the same patients by direct intramuscular approach at LV during CABG.

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
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 31, 2007

Status Verified

May 1, 2007

First QC Date

August 30, 2007

Last Update Submit

August 30, 2007

Conditions

Congestive Heart Failure

Keywords

Stem cellsCoronary Artery Bypass graftingCongestive Heart FailureCoronary Artery DiseaseAngiogenesis

Outcome Measures

Primary Outcomes (5)

  • Evaluation criteria

    3 months

  • Safety : no.& duration of adverse event & serious adverse event

    3 months

  • Efficacy : EF , NYHA

    3 months

  • change from baseline to 1 & 3 months of NYHA, 6-minute walking test

    3 months

  • Change from baseline to 3 months of QoL(SF-36)

    3 months

Secondary Outcomes (4)

  • Efficacy:%EF,NYHA

    3 months

  • change from baseline to 3 months of % LVEF by Echocardiography & C-MRI

    3 months

  • change from baseline to 3 months of % infracted scar area on C-MRI

    3 months

  • change from baseline to 3 months of QoL(SF-36)

    3 months

Study Arms (1)

single arm

EXPERIMENTAL

open lable,single arm , intervention is Angiogenic Cell Precusors(ACPs)

Procedure: Angiogenic Cell Precursors(ACPs) or Vescell TMBiological: Angiogenic Cell Precusors

Interventions

Angiogenic Cell Precursors(ACPs) or Vescell TMPROCEDURE

at least 1.5 million of ACPs per one time of treatment

single arm
Angiogenic Cell PrecusorsBIOLOGICAL

Stem cells type Angiogenic Cell Precusors(ACPs) at least 1.5 million ACPs per each treatment

single arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with or without signs of congestive heart failure due to ischemic heart disease who had maximal medical treatments. Not suitable to percutaneous intervention
  • All patients must have a recent coronary angiogram. Patients must be able to have OPCAB and then have Angiogenic Cell Precursors(ACPs) in non-graftable and/or infraction regions
  • Age 18 to 80 years
  • Male or non-pregnant, non-lactating female
  • MRI demonstrating areas of viable and non-viable myocardium
  • Informed consent obtained and consent form signed

You may not qualify if:

  • Prior Cardiac Surgery or Heart Transplantation
  • Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
  • Inability to communicate (that may interfere with the clinical evaluation of the patient)
  • Acute Myocardial infarction \< 6 days from acute event
  • Significant valvular disease or after valve replacement
  • Left Ventricular Aneurysm
  • Collagen tissue disease
  • History of Prior Radiation Exposure
  • History of alcohol or drug abuse within 3 months of screening
  • Renal failure (creatinine \> 2 mg/dl) or Hemodialysis
  • Hepatic failure or History of Liver Cirrhosis
  • Females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study.
  • Anemia (lower than 11mg/dl.hemoglobin for female and lower than 12 mg/dl for male)
  • Abnormal coagulation tests normal \[platelets, PT (INR), PTT\]
  • Stroke within the preceding 3 years
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theravitae Co.

Tel Viv, P.O. B 4049,Ness Ziona, 74410, Israel

RECRUITING

MeSH Terms

Conditions

Heart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kitipan Visudharom, Ph.D.,M.D.

    Bangkok Heart Hospital, 2 Soi Soonvijai 7,New Petchburi Rd.,Bangkok 10310 Thailand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wannapa Kulwathanaporn, Master

CONTACT

++66-2-664-4290wannapa@theravitae.com

David Czeiger, Ph.D.,M.D.

CONTACT

+972 54-208-0405dudyc@theravitae.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Study Start

January 1, 2006

Study Completion

September 1, 2007

Last Updated

August 31, 2007

Record last verified: 2007-05

Locations

IL(1)