Cell therapy clinical trial researchers

Active Clinical Trials

Cell view from a cell therapy clinical trial

Advancing Regenerative Therapies that Reverse Chronic Disease

We are developing an innovative cell therapy pipeline with the potential to redefine standards of care across a range of conditions where there is an urgent medical need.  We are applying our proprietary CD34+ cell technology to potentially treat a number of conditions caused by underlying ischemic injury, including but not limited to, Coronary Microvascular Dysfunction (CMD), Critical Limb Ischemia (CLI) and Diabetic Kidney Disease (DKD).

Active Clinical Trials

The FREEDOM Trial: Coronary Microvascular Dysfunction

Status: Active; Not Recruiting 

A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of XOWNA® (CLBS16) in subjects with Coronary Microvascular Dysfunction (CMD) and without obstructive coronary artery disease. 

This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous 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 administration of XOWNA® or placebo.

Learn more about the FREEDOM trial on ClinicalTrials.gov (Identifier: NCT04614467) or by visiting freedom-trial.com.

CLBS201: Diabetic Kidney Disease

Status: Actively Recruiting

A Phase 1 open-label, proof-of-concept study to evaluate the safety and efficacy of an autologous CD34+ cell therapy (CLBS201) in subjects with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).

HONEDRA(CLBS12): Critical Limb Ischemia

Status: Follow-up Ongoing

A Phase 2 study in Japan evaluating an autologous CD34+ cell therapy (HONEDRA) for the treatment of critical limb ischemia (CLI).