A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-29

Study Completion Date

2022-09-28

Brief Summary

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This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous CD34+ cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single administration of CLBS16 or placebo.

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Detailed Description

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Conditions

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Coronary Microvascular Dysfunction Coronary Microvascular Disease Microvascular Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GCSF-mobilized autologous CD34+ cells

Group Type EXPERIMENTAL

CLBS16

Intervention Type BIOLOGICAL

GCSF-mobilized autologous CD34+ cells

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

isotonic solution (no CD34+ cells)

Interventions

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CLBS16

GCSF-mobilized autologous CD34+ cells

Intervention Type BIOLOGICAL

Placebo

isotonic solution (no CD34+ cells)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Men or women age ≥18
* History of and currently experiencing angina at least 3 times per week
* Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5 or other measures
* Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina
* No obstructive coronary artery disease
* On stable medical therapy for at least 30 days prior to enrollment
* Must agree to use a reliable and acceptable method of contraception for the duration of participation
* Written informed consent

Exclusion Criteria

* Myocardial infarction within 90 days
* Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
* Diagnosis of other specific cardiac disease
* Must meet LVEF and GFR requirements
* Current use of coumadin or DOACs
* Hypersensitivity to GCSF, apheresis or study product components
* Positive for HIV, hepatitis B or hepatitis C
* Active inflammatory or autoimmune disease, or chronic immunosuppressive state
* Drug abuse
* Pregnant or lactating
* Malignant neoplasm within 5 years
* History of Sickle Cell Disease
* Participation in another clinical study within 90 days prior to informed consent or concurrently with this study
* Previous treatment with a CD34+ cell based therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No