SMSbiotech
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.
SORT-COPD II is a Phase 1b/2a, open-label, non-randomized, single-arm clinical study evaluating an investigational biologic therapy called SORT-COPD in adults with moderate to severe chronic obstructive pulmonary disease (COPD). SORT-COPD consists of Small Mobile Stem (SMS) cells suspended in Hank's Balanced Salt Solution and delivered directly to the lungs as an aerosolized mist using a vibrating mesh nebulizer. SMS cells are small adult stem cells derived from human blood. Laboratory and animal studies suggest that these cells may bind to cells involved in lung repair and influence inflamma…
Inclusion Criteria: 1. Eligible participants must meet all of the following inclusion criteria: 2. Adult \>18 yrs old (inclusive). 3. Female participants: * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: * Is a woman of nonchildbearing potential (WONCBP) OR * Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method from screening until 30 days after the last dose of study intervention. * A WOCBP must have a negative highly sensitive pregnancy test (urine or…
The suspension of Small Mobile Stem (SMS) cells will be placed into a medical nebulizer machine, commonly used to deliver medicines into the lungs through inhalation. Participants with moderate to severe chronic obstructive pulmonary disease (COPD) will breathe in the mist containing the SMS cells through a mouthpiece. The treatment will be given at the study site on Days 1, 3, and 6. Each treatment will contain 2.4 billion SMS cells and will take approximately 30 minutes to complete. This is a Phase 1b/2a study designed to evaluate the safety, tolerability, and potential effects of SMS cells in people with moderate to severe COPD.
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