NCT03455725Active, not recruiting
CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
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)
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 343 (estimated)
- First submitted
- 28 Feb 2018
- Start date
- 30 Jun 2021
- Primary completion date
- 19 Feb 2025
- Lead sponsor
- BioCardia, Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT03455725
What you commit to
- Study type: Interventional
- Planned participants: 343
- From 30 Jun 2021 to the primary completion date, 19 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Who the study is looking for
- Male or female 21 to 80 years of age
- Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
- Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
- Evidence of inducible myocardial ischemia on baseline stress testing
- Obstructive coronary disease unsuitable for conventional revascularization
- Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
- Able to complete an exercise tolerance test on the treadmill
- Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
- Qualification of a pre-procedure screening of bone-marrow aspiration
Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.