SMSbiotech, a San Diego–based leader in regenerative medicine,  announced the initiation of its first-in-human Phase 1 clinical trial for Chronic Obstructive Pulmonary Disease (COPD). This milestone marks the transition of years of dedicated research into clinical development, with the goal of delivering a transformative therapy for millions living with this debilitating lung condition.

On July 11, 2025, at Veritus Research in Melbourne, Australia, the first dose of SMSbiotech’s novel therapeutic candidate was administered to the inaugural patient. 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. The trial is designed to evaluate the safety and preliminary efficacy of SMSbiotech’s Small Mobile Stem (SMS) cells—a unique, healthy, adult blood-derived cell population discovered and named by SMSbiotech.

Unlike traditional treatments, SMS cells are designed to regenerate damaged lung tissue. The off-the-shelf, non-invasive therapy is administered directly to the lungs through a nebulizer. Preclinical studies demonstrated significant restoration of lung function in as little as 10 days. The study duration is expected to be 15 months.

“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 also encouraged to report that the first two sentinel patients have been dosed, initial safety data has been received, and the trial can now move forward—an important validation step as we continue this study. 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. 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.”

The trial received regulatory approval from the Therapeutic Goods Administration (TGA), Australia’s regulatory authority equivalent to the U.S. Food and Drug Administration (FDA).

SMSbiotech has filed 16 patents and received 7 granted patents for its technology. Pending sufficient safety data from this trial, the company plans to evaluate compassionate use applications. Encouraged by promising preclinical data, SMSbiotech is also investigating applications in orthopedics and other therapeutic areas.