CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

Description

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment Treatment Group: Subjects treated with aBMC using the CardiAMP cell therapy system Sham Control Group: Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

Conditions

Refractory Angina, Chronic Myocardial Ischemia

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Study Overview

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Study Details

Study overview

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment Treatment Group: Subjects treated with aBMC using the CardiAMP cell therapy system Sham Control Group: Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)

CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

Condition
Refractory Angina
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Madison

University of Wisconsin Madison, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female 21 to 80 years of age
  • 2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
  • 3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
  • 4. Evidence of inducible myocardial ischemia on baseline stress testing
  • 5. Obstructive coronary disease unsuitable for conventional revascularization
  • 6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
  • 7. Able to complete an exercise tolerance test on the treadmill
  • 8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
  • 9. Qualification of a pre-procedure screening of bone-marrow aspiration

Ages Eligible for Study

21 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BioCardia, Inc.,

Amish Raval, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

2026-12