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| Sponsor: | Aastrom Biosciences |
|---|---|
| Information provided by: | Aastrom Biosciences |
| ClinicalTrials.gov Identifier: | NCT01020968 |
Purpose
This study is designed to assess the safety profile and the efficacy of cardiac repair cells (CRCs) administered via catheter in treating patients with dilated cardiomyopathy (DCM).
| Condition | Intervention | Phase |
|---|---|---|
|
Dilated Cardiomyopathy |
Biological: Cardiac Repair Cells (CRCs) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Catheter-based Transendocardial Delivery of Autologous Bone Marrow-Derived Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy |
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
The Treatment arm of the study will receive standard of care therapy, a bone marrow aspiration and catheter-based injections of the study cellular product.
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Biological: Cardiac Repair Cells (CRCs)
CRCs will be administered via catheter-based injection to the endocardial surface of the left ventricle.
Other Name: autologous bone marrow cells
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No Intervention: Control
Standard-of-care therapy will be provided for DCM condition only. Patients in this group may be offered the opportunity to receive CRC treatment in a separate open-label cross-over protocol after completing at least 6 months of treatment. However, before a cross-over protocol becomes available, an independent data and safety monitoring board (DSMB), the FDA and the Sponsor will review 6-month safety and efficacy data from the first 10 CRC-treated patients and the risk-benefit profile in order to assess the value and utility of such a protocol. If a cross-over protocol becomes available, the investigators will assess the status of an individual control patient, discuss the cross-over option with the patient, and will ensure that the patient meets the eligibility criteria of the cross-over protocol in order to qualify for CRC treatment.
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Heart failure remains a major public health problem, affecting 5 million patients in the US, with 550,000 new diagnoses made each year (Hunt SA; et al., 2005). Heart failure is the leading cause of hospitalization in persons over 65 years of age with cost exceeding $29 billion annually. Prognosis is very poor once a patient has been hospitalized with heart failure. The mortality risk after heart failure hospitalization is 11.3% at 30 days, 33.1% at 1 year and well over 50% within 5 years (Hunt SA; et al., 2005). These numbers emphasize the need to develop and implement more effective treatments to manage heart failure.
Aastrom is targeting a subset of heart failure patient population, namely those diagnosed with dilated cardiomyopathy. The World Health Organization (WHO) defines dilated cardiomyopathy (DCM) as a cardiac condition wherein a ventricular chamber exhibits increased diastolic and systolic volume and a low (<40%) ejection fraction (Manolio TA; et al., 1992; Towbin JA; et al., 2006). DCM is reported to affect 108,000 to 150,000 patients in the United States (Richardson P; et al., 1996; Towbin JA; et al., 2006).
This study is a prospective, stratified, randomized, open-label, controlled, multi-center study to assess the safety profile and the efficacy of CRCs administered via catheter in treating patients with DCM. Two strata will be used: ischemic (IDCM) and non-ischemic (NIDCM). Within each stratum, patients will be randomized to receive either CRC treatment or control in a 2:1 ratio (8 patients per CRC treatment group and 4 patients per control group). It will enroll a total of 24 patients at 2 sites in the U.S.
Eligibility| Ages Eligible for Study: | 18 Years to 86 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| Minneapolis Heart Institute | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Ohio | |
| University Hospitals, Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| Principal Investigator: | Timothy Henry, MD | Minneapolis Heart Institute Foundation |
More Information
| Responsible Party: | Elmar R. Burchardt, MD, PhD, Aastrom Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01020968 History of Changes |
| Other Study ID Numbers: | ABI-55-0811-1 |
| Study First Received: | November 25, 2009 |
| Last Updated: | January 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Ischemic Dilated Cardiomyopathy Non-Ischemic Dilated Cardiomyopathy |
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Cardiomyopathy, Dilated Heart Failure Cardiomyopathies |
Cardiomegaly Heart Diseases Cardiovascular Diseases |