Clinical trial NCT03508609: Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Microvascular Dysfunction
Lead sponsor: Lisata Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Cedars-Sinai Medical Center
name: Mayo Clinic
First posted: 2018-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Coronary Flow Reserve
timeFrame: Day 180
Secondary outcomes:
measure: Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine
timeFrame: Day 180
measure: Change From Baseline in Peripheral Arterial Tonometry
timeFrame: Day 180
measure: Change in Angina Frequency From Baseline
timeFrame: 6 months
measure: Canadian Cardiovascular Society Angina Class
timeFrame: 6 months
measure: Change From Baseline in Seattle Angina Questionnaire
timeFrame: 6 months
measure: Change From Baseline in SF-36 Scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Chief Medical Officer
name: Douglas W. Losordo, MD
role: STUDY_DIRECTOR
References:
citation: Henry TD, Bairey Merz CN, Wei J, Corban MT, Quesada O, Joung S, Kotynski CL, Wang J, Lewis M, Schumacher AM, Bartel RL, Takagi H, Shah V, Lee A, Sietsema WK, Losordo DW, Lerman A. Autologous CD34+ Stem Cell Therapy Increases Coronary Flow Reserve and Reduces Angina in Patients With Coronary Microvascular Dysfunction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010802. doi: 10.1161/CIRCINTERVENTIONS.121.010802. Epub 2022 Jan 23.
citation: Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.