MELBOURNE, Australia — SMSbiotech, a San Diego–based regenerative medicine company, has begun its first human clinical trial testing a novel stem cell therapy for chronic obstructive pulmonary disease (COPD), a condition that affects millions worldwide.
The trial, launched on July 11 at Veritus Research in Melbourne, administered the first dose of SMSbiotech’s experimental treatment to a patient aged between 39 and 69. Over the course of the 15-month Phase 1 study, 18 participants will be enrolled to assess both the safety and preliminary efficacy of the company’s Small Mobile Stem (SMS) cells, a proprietary population of adult blood-derived cells discovered and developed by the company.
Unlike conventional COPD treatments that manage symptoms, SMS cells are designed to regenerate damaged lung tissue. Delivered through a nebulizer, the off-the-shelf therapy showed promising results in preclinical studies, with measurable restoration of lung function observed in as little as 10 days.
“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. 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 study has already treated two sentinel patients and received initial safety data allowing it to proceed, according to the company. The trial received regulatory approval from Australia’s Therapeutic Goods Administration, equivalent to the U.S. Food and Drug Administration.
SMSbiotech has filed 16 patents and secured seven granted patents for its technology. Pending favorable safety data, the company may explore compassionate use applications for patients and is also investigating broader uses of its SMS cell technology in orthopedics and other therapeutic areas.
