Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
- Conditions
- Coronary Microvascular Dysfunction
- Interventions
- Biological: CLBS16
- Registration Number
- NCT03508609
- Lead Sponsor
- Lisata Therapeutics, Inc.
- Brief Summary
This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected 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 intracoronary infusion of CLBS16.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Men or women age ≥18
- History of and currently experiencing angina at least 3 times per week
- No obstructive coronary artery disease
- On stable medical therapy for 30 days prior to enrollment
- Must agree to use a reliable and acceptable method of contraception for the duration of participation
- Written informed consent
- 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 G-CSF, 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Autologous CD34 cells CLBS16 Open label active treatment arm. Subjects receive autologous CD34 cells.
- Primary Outcome Measures
Name Time Method Change From Baseline in Coronary Flow Reserve Day 180 Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Peripheral Arterial Tonometry Day 180 Change in Angina Frequency From Baseline 6 months Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine Day 180 Change From Baseline in Seattle Angina Questionnaire 6 months The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Change From Baseline in SF-36 Scores 6 months The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Canadian Cardiovascular Society Angina Class 6 months Canadian Cardiovascular Society angina class grading scale is assessed according to the following scores:
Grade 1: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation Grade 2: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions Grade 3: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace Grade 4: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest A higher grade is a worse outcome.
Trial Locations
- Locations (2)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States