CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (CardiAMP-CMI)

BioCardia

Status: Active, not recruiting

Conditions: Chronic Myocardial Ischemia; Refractory Angina

Treatments: Other: Sham Treatment; Device: CardiAMP Cell Therapy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03455725

04747 (CLIN)

Details and patient eligibility

About

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)

Enrollment: 343 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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343 participants in 2 patient groups

CardiAMP cell therapy system

Active Comparator group

Description:

Roll-in phase: Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase. In the subsequent randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system.

Treatment:

Device: CardiAMP Cell Therapy System

Sham procedure control

Sham Comparator group

Description:

Randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells)

Treatment:

Other: Sham Treatment