Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
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| ClinicalTrials.gov Identifier: NCT03508609 |
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Recruitment Status :
Completed
First Posted : April 26, 2018
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Microvascular Dysfunction | Biological: CLBS16 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease |
| Actual Study Start Date : | April 19, 2018 |
| Actual Primary Completion Date : | December 10, 2019 |
| Actual Study Completion Date : | May 5, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Autologous CD34 cells
Open label active treatment arm. Subjects receive autologous CD34 cells.
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Biological: CLBS16
GCSF-mobilized autologous CD34 cells |
- Change From Baseline in Coronary Flow Reserve [ Time Frame: Day 180 ]Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
- Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine [ Time Frame: Day 180 ]
- Change From Baseline in Peripheral Arterial Tonometry [ Time Frame: Day 180 ]
- Change in Angina Frequency From Baseline [ Time Frame: 6 months ]
- Canadian Cardiovascular Society Angina Class [ Time Frame: 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.
- Change From Baseline in Seattle Angina Questionnaire [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508609
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| Study Director: | Douglas W. Losordo, MD | Chief Medical Officer |
Documents provided by Caladrius Biosciences, Inc.:
| Responsible Party: | Caladrius Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT03508609 |
| Other Study ID Numbers: |
CLBS16-P01 1R44HL135889-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 26, 2018 Key Record Dates |
| Results First Posted: | January 8, 2021 |
| Last Update Posted: | January 8, 2021 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |