SMSbiotech, a San Diego-based regenerative medicine company, has initiated its first-in-human Phase 1 clinical trial for Chronic Obstructive Pulmonary Disease (COPD), marking a significant milestone in the development of novel stem cell therapies for respiratory conditions. The first patient received the experimental treatment on July 11, 2025, at Veritus Research in Melbourne, Australia.
Novel Stem Cell Approach to COPD Treatment
The Phase 1 study, titled "A study to investigate small mobile stem cells (SMS cells) in participants aged 39 to 69 years with chronic obstructive pulmonary disease," will enroll 18 COPD patients over an expected 15-month duration. The trial is designed to evaluate the safety and preliminary efficacy of SMSbiotech's Small Mobile Stem (SMS) cells, described as a unique, healthy, adult blood-derived cell population discovered and named by the company.
Unlike traditional COPD treatments that focus on symptom management, SMS cells are designed to regenerate damaged lung tissue. The therapy represents an innovative approach as an off-the-shelf, non-invasive treatment administered directly to the lungs through a nebulizer, potentially offering a more convenient delivery method compared to invasive procedures.
Promising Preclinical Results
Preclinical studies of the SMS cell therapy demonstrated significant restoration of lung function in as little as 10 days, suggesting rapid therapeutic effects. This timeline represents a potentially dramatic improvement over conventional COPD treatments, which typically focus on slowing disease progression rather than tissue regeneration.
"The initiation of our Phase 1 trial for COPD is a profound moment for SMSbiotech and, more importantly, for the millions of patients yearning for better treatment options," said Dr. Abdulkader Rahmo, President of SMSbiotech. "We are immensely optimistic about the potential of our Small Mobile Stem cell therapy to not only manage COPD symptoms but to fundamentally alter the disease's progression and potentially reverse its devastating effects."
Early Safety Data and Regulatory Approval
The company reported encouraging initial results, with the first two sentinel patients having been dosed and initial safety data received, allowing the trial to move forward. This represents an important validation step in the clinical development process.
The trial has received regulatory approval from the Therapeutic Goods Administration (TGA), Australia's regulatory authority equivalent to the U.S. Food and Drug Administration (FDA), providing regulatory validation for the novel therapeutic approach.
Intellectual Property and Future Applications
SMSbiotech has established a strong intellectual property portfolio around its SMS cell technology, having filed 16 patents with 7 already granted. The company indicates that pending sufficient safety data from the current trial, it plans to evaluate compassionate use applications for patients with urgent medical needs.
Beyond COPD, the company is investigating applications of its SMS cell technology in orthopedics and other therapeutic areas, suggesting broader potential applications for the regenerative medicine platform.
Dr. Rahmo emphasized the transformative potential of the therapy, stating, "We believe this represents a new dawn for respiratory medicine, offering the promise of a future where patients can breathe easier and live fuller lives."
