CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

NCT03455725 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 04747 (CLIN)
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 2

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)

Conditions

Refractory Angina; Chronic Myocardial Ischemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol

  A superiority analysis with regards to change from Baseline in Total Exercise Time at the 6 months follow-up visit (using a Modified Bruce Protocol).

  Baseline and 6 months visit

Secondary Outcomes (7)

• Safety: overall survival at 6 months follow-up

  at 6 months follow-up

• Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up

  from randomisation to 6 months follow-up

• Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up

  Baseline and at 6 months follow-up

• Efficacy: Change of angina frequency (per week) at 12 months follow-up

  Baseline and at 12 months follow-up

• Efficacy: Change of Angina Frequency (per week) at 6 months follow-up

  Baseline and at 6 months follow-up

Study Arms (2)

CardiAMP cell therapy system

ACTIVE COMPARATOR

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.

Device: CardiAMP Cell Therapy System

Sham procedure control

SHAM COMPARATOR

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)

Other: Sham Treatment

Interventions

CardiAMP Cell Therapy System DEVICE

The CardiAMP Cell Therapy system consists of the CardiAMP Potency Assay, the Helix/Morph intramyocardial delivery catheter system, and the CardiAMP Cell Separator. The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay), to isolate the stem cells from a bone marrow harvest at the point of care (using the CardiAMP CS system), and to percutaneously inject the autologous cells into the myocardium using the Helix/Morph delivery catheters.

CardiAMP cell therapy system

Sham Treatment OTHER

Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed

Sham procedure control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.

Sponsors & Collaborators

• BioCardia, Inc.: lead

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

Location

Related Links

• company website

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amish Raval, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple-blinded, placebo-controlled study. Patients, investigators, the CRO, core labs and the sponsor will be blinded for individual treatment adjudication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 7, 2018
• Study Start: June 30, 2021
• Primary Completion: February 19, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)