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CLBS16

Phase 2

Coronary Microvascular Dysfunction | Monoclonal antibody | Cardiovascular |Lisata Therapeutics, Inc.|Last Updated: Jan 8, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03508609Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery DiseasePHASE2 COMPLETED 20Apr 19, 2018May 5, 2020Jan 8, 20212 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Coronary Flow Reserve
Day 180

Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.

Secondary Endpoints
Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine
Day 180
Change From Baseline in Peripheral Arterial Tonometry
Day 180
Change in Angina Frequency From Baseline
6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Autologous CD34 cellsEXPERIMENTALOpen label active treatment arm. Subjects receive autologous CD34 cells.
Interventions
NameTypeDescription
CLBS16BIOLOGICALGCSF-mobilized autologous CD34 cells
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

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 dura...

Countries:United States
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