Cell therapy for chronic heart pain
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)
This study tests whether a new cell therapy can help people with chronic heart pain feel better and improve their heart function compared to a placebo treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 343 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | BioCardia, Inc. Industry-sponsored |
| Locations | 2 sites (Gainesville, Florida and 1 other locations) |
| Trial ID | NCT03455725 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of the CardiAMP cell therapy system in treating patients with refractory angina and chronic myocardial ischemia. It is a multi-center, randomized, sham-controlled, and double-blinded study comparing the actual treatment with a sham procedure. Participants will receive either the active bone marrow cell therapy or a placebo treatment, with the aim of assessing improvements in angina symptoms and overall heart function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 80 with severe refractory angina who have not responded to maximum doses of anti-angina medications.
Not a fit: Patients with other significant cardiac or vascular conditions or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce angina symptoms and improve quality of life for patients with chronic heart pain.
How similar studies have performed: Other studies using stem cell therapies for heart conditions have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Where this trial is running
Gainesville, Florida and 1 other locations
- University of Florida — Gainesville, Florida, United States (Recruiting)
- University of Wisconsin Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Amish Raval, MD — University of Wisconsin, Madison
- Study coordinator: Peter Altman, PhD
- Email: info@biocardia.com
- Phone: (650) 226 0135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.