RECRUITING

CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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)

Quick Facts

Study Start:2021-06-30
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03455725

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.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female 21 to 80 years of age
  2. 2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
  3. 3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
  4. 4. Evidence of inducible myocardial ischemia on baseline stress testing
  5. 5. Obstructive coronary disease unsuitable for conventional revascularization
  6. 6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
  7. 7. Able to complete an exercise tolerance test on the treadmill
  8. 8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
  9. 9. Qualification of a pre-procedure screening of bone-marrow aspiration
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Peter Altman, PhD
CONTACT
(650) 226 0135
info@biocardia.com

Principal Investigator

Amish Raval, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610
United States
University of Wisconsin Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: BioCardia, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-30
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-06-30
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Cardiovascular Stem Cell Therapy
  • Bone Marrow Mononuclear Stem Cells
  • Intramyocardial Injection

Additional Relevant MeSH Terms

  • Refractory Angina
  • Chronic Myocardial Ischemia