NCT00523224

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

Status unknown Phase 1 Last updated 30 August 2007

What this trial tests

Phase 1 trial testing Angiogenic Cell Precursors(ACPs) or Vescell TM in Congestive Heart Failure in 5 participants. Status unknown.

Timeline

1 January 2006

1 September 2007

Quick facts

Lead sponsor	TheraVitae Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 January 2006
Estimated completion	1 September 2007
Sites	1 location across Israel

Drugs / interventions tested

• Angiogenic Cell Precursors(ACPs) or Vescell TM
• Angiogenic Cell Precusors — full drug profile →

Conditions studied

• Congestive Heart Failure — all drugs for Congestive Heart Failure →

Sponsor

TheraVitae Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluation criteria
  Time frame: 3 months
• Safety : no.& duration of adverse event & serious adverse event
  Time frame: 3 months
• Efficacy : EF , NYHA
  Time frame: 3 months
• change from baseline to 1 & 3 months of NYHA, 6-minute walking test
  Time frame: 3 months
• Change from baseline to 3 months of QoL(SF-36)
  Time frame: 3 months

Sponsor's own description

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. 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. 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. Age 18 to 80 years
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.

The study consists of 4 periods: Screening ( D-14 to-9\& D-8,Treatment(D0),Acute Safety follow-up (D1-2\& D5-discharge),Chronic follow-up (D30 \& D90)period ,total follow-up of each case is 3 months.

Evaluation criteria :

Safety : no.\& duration of adverse event \& serious adverse event Efficacy :NYHA, 6-minute walking test ,% LVEF by Echocardiography \& C-MRI, % infracted scar area on C-MRI , Pro-BNP \& 3 months of QoL(SF-36)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.