drugset / Trial / NCT03508609
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Phase 2
Completed
20 enrolled
Lisata Therapeutics, Inc.
Cedars-Sinai Medical Center · collabMayo Clinic · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-04-19
- Primary completion
- 2019-12-10
- Completion
- 2020-05-05
Outcome
Met primary endpoint
release “CLBS16 ESCaPE-CMD data presented at American Heart Association 2019 Scientific Sessions demonstrated highly statistically significant improvement in coronary flow reserve and angina symptoms” lisata.com ↗
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CLBS16 | Cell therapy | — | Other |