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REGEND001 cell therapy

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |cbdMD, Inc.|Last Updated: Jul 31, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

REGEND001 cell therapy · 1 trial · 1 indication

Phase 2 1
NCT05638776Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell TherapyChronic Obstructive Pulmonary Disease
COMPLETED58 Analytics
PHASE2COMPLETED
Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change of lung diffusing capacity for carbon monoxide (DLCO) from baseline
Within 52 weeks after treatment

DLCO is considered a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.

Secondary Endpoints

Change of the alveolar volume (VA) from baseline
Winthin 52 weeks after treatment
Change of images of lung by high resolution computed tomography (HR-CT) from baseline
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
Change of forced vital capacity (FVC) from baseline
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
REGEND001 cell therapyEXPERIMENTALREGEND001 cell therapy
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
REGEND001 cell therapyDRUGTransplantation of the cell product
PlaceboDRUGTransplantation of Placebo
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Male or female, aged 40 to 75 at the time of signing informed consent. * Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD). * The ratio of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)FEV1/FVC is...

Countries:China
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Frequently asked questions about REGEND001 cell therapy

What is REGEND001 cell therapy used for?

REGEND001 cell therapy is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD), specifically in patients with a diffusion capacity defect. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes REGEND001 cell therapy?

REGEND001 cell therapy is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational therapy for Chronic Obstructive Pulmonary Disease.

What phase is REGEND001 cell therapy in?

REGEND001 cell therapy is in Phase 2 clinical development. It is an investigational therapy for Chronic Obstructive Pulmonary Disease and has not been approved by the FDA or other regulatory agencies. The therapy remains under clinical investigation to evaluate its safety and efficacy.

What clinical trials is REGEND001 cell therapy in?

REGEND001 cell therapy has one completed clinical trial, identified as NCT05638776, titled "Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy." This Phase 2 trial enrolled 58 participants in China and was placebo-controlled, though it was not double-blinded.

Is REGEND001 cell therapy the same as other COPD treatments?

REGEND001 cell therapy is a distinct investigational therapy being developed specifically for Chronic Obstructive Pulmonary Disease with a diffusion capacity defect. No alternative names for this therapy have been reported. It is currently in Phase 2 clinical trials and has not been approved for commercial use.