Stem Cells for COPD
(SORT-COPD II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is a phase 1b/2a, open-label, non-randomized, observation of 125 adults, with moderate to severe chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells).
The primary objective of this study is to evaluate the preliminary within-participant changes of SORT-COPD (SMS cells), in suspension, delivered to the lung as an aerosolized mist via a vibrating mesh nebulizer, on respiratory health status in participants with moderate to severe chronic obstructive pulmonary disease.
Who Is on the Research Team?
Trishul Siddharthan, Medical Doctor
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe chronic obstructive pulmonary disease (COPD). Participants should have a confirmed diagnosis of COPD and be able to receive treatment through inhalation. People with other serious health issues or certain lung conditions may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- SORT-COPD (SMS cells)
Trial Overview
The study is testing the safety and effects of small mobile stem cells (SMS) delivered as an inhaled mist using a nebulizer in people with moderate to severe COPD. All participants will receive the stem cell treatment; there is no placebo group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive 2.4 billion SMS cells by oral inhalation via vibrating mesh nebulizer on Days 1, 3, and 6 (total: 7.2 billion cells). Safety and tolerability are reviewed by an independent DSMC through Day 28 prior to Phase 2a enrollment.
Participants receive the same treatment regimen as Cohort 1: 2.4 billion SMS cells by oral inhalation via vibrating mesh nebulizer on Days 1, 3, and 6 (total: 7.2 billion cells), following DSMC review of Phase 1b safety data.
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Who Is Running the Clinical Trial?
SMSbiotech
Lead Sponsor
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