Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
NCT ID: NCT03508609
Last Updated: 2021-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2018-04-19
2020-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous CD34 cells
Open label active treatment arm. Subjects receive autologous CD34 cells.
CLBS16
GCSF-mobilized autologous CD34 cells
Interventions
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CLBS16
GCSF-mobilized autologous CD34 cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Cedars-Sinai Medical Center
OTHER
Mayo Clinic
OTHER
Lisata Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas W. Losordo, MD
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLBS16-P01
Identifier Type: -
Identifier Source: org_study_id
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