Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)

NCT ID: NCT00203203

Last Updated: 2016-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2009-11-30

Brief Summary

This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where left ventricular electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed stem cells are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow up visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.

Detailed Description

This is a phase 1, single-blind trial to evaluate the use of autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease is safe, can promote neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study will be to evaluate the safety of autologous-bone-marrow mononuclear cell injections. The secondary endpoint of the study is to assess the efficacy of autologous bone marrow cells in improving cardiac contractile function and functional outcome. The efficacy will be assessed on the basis of the treadmill Max VO2 (maximum volume oxygen uptake). Secondarily the efficacy will be assessed on the basis of clinical status and imaging rests, with follow-up extending to 1 year after enrollment.A maximum of 30 patients will be enrolled in the study. At the end of the 6-month visit. after the required angiogram with mapping and non-invasive testing is complete, the patients will be told whether they were in the control or the active group (stem cell therapy). Those in the control group will be told before final invasive testing, and those who consent may cross over to the active therapy arm and undergo the cell injection procedure (control, then stem cell therapy. In these patients, the foll-up angiogram and mapping procedure will also serve as the baseline procedure required for cell injection. Bone marrow mononuclear cells will be injected in an identical fashion, according to the same criteria described for the original treatment group, and these patients will have identical follow-up visits starting again at the baseline time-point and extending for up to 1 year.

Conditions

Ischemic Cardiomyopathy

Keywords

Autologous; Cardiac; Stem Cell; Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stem Cell Therapy

Subject is randomized to receive Stem Cell Therapy (intramyocardial injection of stem cells) via NOGA mapping.

Group Type: EXPERIMENTAL

Intramyocardial Injection of stem cells via NOGA Mapping

Intervention Type: DEVICE

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.

Control, then Stem Cell Therapy

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Group Type: OTHER

Control, then Stem Cell Therapy

Intervention Type: OTHER

Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.

Interventions

Intramyocardial Injection of stem cells via NOGA Mapping

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.

Intervention Type: DEVICE

Control, then Stem Cell Therapy

Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.

Intervention Type: OTHER

Other Intervention Names

NOGA Star catheter and Myostar Injection.; cross-over

Eligibility Criteria

Inclusion Criteria

• LVEF less than 45%
• Functional class III or IV angina
• At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT) nuclear study
• there are additional inc. criteria

Exclusion Criteria

• AGe <18 or >70 years of age
• Constant atrial fibrillation
• Left ventricular (LV) thrombus
• History of malignancy in the last 5 years
• LV wall thickness of < 8 mm at the target site

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHI St. Luke's Health, Texas

OTHER

Sponsor Role: collaborator

Texas Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Emerson Perin, MD, PhD

Director Clinical Research for Cardiovascular Medicine and Director Stem Cell Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emerson Perin, MD,PhD.

Role: PRINCIPAL_INVESTIGATOR

Texas Heart Institute/Baylor St Luke's Medical Center

Locations

Texas Heart Institute/Baylor St. Luke's Medical Center

Houston, Texas, United States

Countries

United States

References

Perin EC, Silva GV, Henry TD, Cabreira-Hansen MG, Moore WH, Coulter SA, Herlihy JP, Fernandes MR, Cheong BY, Flamm SD, Traverse JH, Zheng Y, Smith D, Shaw S, Westbrook L, Olson R, Patel D, Gahremanpour A, Canales J, Vaughn WK, Willerson JT. A randomized study of transendocardial injection of autologous bone marrow mononuclear cells and cell function analysis in ischemic heart failure (FOCUS-HF). Am Heart J. 2011 Jun;161(6):1078-87.e3. doi: 10.1016/j.ahj.2011.01.028. Epub 2011 May 10.

Reference Type: RESULT

PMID: 21641354 (View on PubMed)

Related Links

http://www.texasheart.org/stemcell

Stem Cell Group at Texas Heart Institute

Other Identifiers

HSC-MS-04-141

Identifier Type: -

Identifier Source: org_study_id