Clinical trial NCT03455725: CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Angina
Chronic Myocardial Ischemia
Keywords: Cardiovascular Stem Cell Therapy
Bone Marrow Mononuclear Stem Cells
Intramyocardial Injection
Lead sponsor: BioCardia, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 343
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center, 2:1 randomized (Treatment vs Sham Control), blinded trial comparing 2 paralel groups of patients with CMI treated with CardiAMP cell therapy system vs sham treatment.
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol
timeFrame: Baseline and 6 months visit
Secondary outcomes:
measure: Safety: overall survival at 6 months follow-up
timeFrame: at 6 months follow-up
measure: Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up
timeFrame: from randomisation to 6 months follow-up
measure: Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up
timeFrame: Baseline and at 6 months follow-up
measure: Efficacy: Change of angina frequency (per week) at 12 months follow-up
timeFrame: Baseline and at 12 months follow-up
measure: Efficacy: Change of Angina Frequency (per week) at 6 months follow-up
timeFrame: Baseline and at 6 months follow-up
measure: Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up
timeFrame: From randomisation to 12 month follow-up
measure: Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE)
timeFrame: From randomization to 12 Months follow-up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Amish Raval, MD
role: PRINCIPAL_INVESTIGATOR
References: