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CLBS16

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

CLBS16 · 1 trial · 1 indication

Phase 2 1
NCT03508609Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery DiseaseCoronary Microvascular Dysfunction
COMPLETED20 Analytics
PHASE2COMPLETED
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction
NCT0350860920
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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 to 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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Frequently asked questions about CLBS16

What is CLBS03 Low Dose used for?

CLBS03 Low Dose is an investigational cell therapy being studied for use in diabetes mellitus, specifically in adolescents with recent onset type 1 diabetes. It is in Phase 2 clinical development and is not yet approved by the FDA.

Who makes CLBS03 Low Dose?

CLBS03 Low Dose is being developed by Lisata Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol LSTA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.

What phase is CLBS03 Low Dose in?

CLBS03 Low Dose is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness.

What clinical trials is CLBS03 Low Dose in?

CLBS03 Low Dose was evaluated in a completed Phase 2 clinical trial with NCT number NCT02691247, titled 'Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes.' This trial enrolled 113 participants in the United States.

Is CLBS03 Low Dose the same as CLBS03?

CLBS03 Low Dose is a specific dosage form of the investigational therapy CLBS03. The clinical trial NCT02691247 studied CLBS03 in adolescents with recent onset type 1 diabetes, and the low dose refers to one of the dosage levels being evaluated in that study.