SMSbiotech Advances to First-in-Human Phase 1 Clinical Trial for COPD with Innovative Stem Cell Therapy
San Diego-based regenerative medicine company begins groundbreaking trial in Australia, aiming to restore lung function in millions of patients worldwide. SMSbiotech, a biotechnology company headquartered in San Diego, California, announced a major milestone in its mission to redefine treatment for chronic lung disease: the initiation of its first-in-human Phase 1 clinical trial for Chronic Obstructive Pulmonary Disease (COPD). The development represents the culmination of years of research into cellular regeneration and marks the beginning of a bold new chapter in clinical development for the company.
On July 11, 2025, at Veritus Research in Melbourne, Australia, the first dose of SMSbiotech’s novel therapeutic candidate was administered to a patient, marking the official start of the company’s landmark study. The clinical trial, formally 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 patients diagnosed with COPD.
The primary goal of this Phase 1 trial is to establish safety and tolerability, while also providing early signals of efficacy. SMSbiotech’s novel Small Mobile Stem (SMS) cells—a unique population of healthy, adult blood-derived cells discovered and named by the company—will serve as the therapeutic backbone of the study. These cells are designed to achieve what conventional COPD therapies cannot: the regeneration of damaged lung tissue.
COPD: A Major Unmet Medical Need
COPD remains one of the world’s most prevalent and deadly chronic diseases. Characterized by progressive airflow limitation, breathlessness, chronic cough, and frequent exacerbations, COPD affects more than 390 million people globally. It is currently the third leading cause of death worldwide, responsible for over 3 million deaths each year, according to the World Health Organization.
Despite its massive burden, current therapies are limited to symptom management. Available medications—such as bronchodilators, inhaled corticosteroids, and oxygen therapy—can provide temporary relief but do not reverse or repair the structural damage to lung tissue that lies at the heart of the disease.
“Patients SMSbiotech diagnosed with COPD often face a life of progressive decline,” explained Dr. Abdulkader Rahmo, President of SMSbiotech. “They experience reduced quality of life, limited physical capacity, and the constant threat of acute flare-ups. At present, there is no treatment that addresses the root cause of the disease, which is why regenerative medicine holds such promise.”
A Novel Therapeutic Approach: Small Mobile Stem (SMS) Cells
At the center of SMSbiotech’s therapeutic strategy is its proprietary discovery of Small Mobile Stem cells, which distinguish themselves from other regenerative cell types by their unique properties. Derived from healthy adult blood, SMS cells are small in size, highly mobile, and can be delivered in an off-the-shelf format.
Unlike SMSbiotech invasive procedures such as bone marrow transplants or complex cell extractions, SMS cells offer a non-invasive and scalable solution. For COPD patients, the therapy is delivered via a nebulizer, allowing the cells to be inhaled directly into the lungs. Once administered, SMS cells target damaged tissue with the potential to regenerate lung structures, repair inflammatory damage, and improve pulmonary function.
In preclinical models, SMS cells demonstrated remarkable effects. Laboratory studies showed restoration of lung function within as little as 10 days, alongside evidence of tissue repair and reduction in markers of chronic inflammation.
“This is not simply another therapy to ease symptoms,” Dr. Rahmo noted. “Our goal is to address the underlying tissue damage and provide patients with the possibility of not just slowing their decline but actually regaining function.”
Phase 1 Trial Design and Objectives
The 15-month clinical trial is designed as a first-in-human safety and feasibility study. A total of 18 participants between the ages of 39 and 69 years with moderate to severe COPD will be enrolled. The initial dosing was conducted with two sentinel patients—a standard precaution in early-phase studies—before progressing to broader patient enrollment.
The primary endpoint is safety, with researchers carefully monitoring participants for adverse events. Secondary endpoints will include measures of lung function, exercise tolerance, symptom relief, and potential regenerative effects.
Already, SMSbiotech has reported encouraging early progress. “We are pleased to share that the first two sentinel patients have been successfully dosed, initial safety data has been received, and the trial is now moving forward,” said Dr. Rahmo. “This important validation step strengthens our confidence in the program.”
Regulatory Pathway and Oversight
The clinical trial was authorized by the Therapeutic Goods Administration (TGA), Australia’s regulatory authority, which functions as the equivalent of the U.S. Food and Drug Administration (FDA). Australia has become an increasingly attractive destination for early-stage clinical trials due to its efficient regulatory processes, robust research infrastructure, and internationally recognized standards.
TGA approval ensures that the trial is conducted under rigorous standards of patient safety, data integrity, and ethical oversight.
Intellectual Property and Pipeline Expansion
SMSbiotech has been proactive in protecting its innovations. To date, the company has filed 16 patents related to its stem cell technology and has been granted 7 patents. These cover not only COPD applications but also potential uses in other therapeutic areas.
Encouraged by its preclinical success, SMSbiotech is exploring additional applications of SMS cells, including in orthopedics and other degenerative conditions where tissue regeneration could provide transformative outcomes.
Should early safety data support further development, the company intends to evaluate compassionate use applications, allowing select patients with severe unmet needs to access therapy prior to full regulatory approval.
A Patient-Centered Vision
The human toll of COPD goes beyond clinical statistics. Patients often experience a progressive loss of independence, with daily activities—such as walking, climbing stairs, or even speaking for extended periods—becoming increasingly difficult. Families, caregivers, and healthcare systems all bear the burden of the disease.
For this reason, SMSbiotech has placed patients at the center of its mission. “Our vision is not just to prolong life but to restore quality of life,” emphasized Dr. Rahmo. “We believe our approach could represent a new dawn for respiratory medicine, offering the promise of a future where patients can breathe easier and live fuller lives.”
The Broader Impact on Respiratory Medicine
If successful, SMSbiotech’s work could redefine therapeutic approaches in respiratory medicine. By proving that regenerative cell therapies can be delivered via simple, non-invasive inhalation, the company may pave the way for a new category of treatments applicable not only to COPD but also to other chronic lung diseases, such as pulmonary fibrosis and severe asthma.
Furthermore, the trial reflects a growing recognition of the role regenerative medicine can play in addressing chronic diseases traditionally considered irreversible. Similar approaches are being explored in cardiac, neurological, and musculoskeletal conditions, positioning cell-based therapies as a central pillar of 21st-century medicine.
With the Phase 1 study now underway, SMSbiotech’s progress will be closely monitored by the scientific community, investors, and—most importantly—patients and families affected by COPD. Results from the trial, expected over the next 15 months, will determine whether SMS cells can fulfill their promise as a safe and effective therapy.
The initiation of this trial is both a scientific milestone and a symbol of hope. While challenges remain, the progress underscores the potential of regenerative medicine to achieve what once seemed impossible: the restoration of human health at the cellular level.
Access to Trial Information
Patients, clinicians, and researchers interested in learning more about the ongoing Phase 1 trial can access full details through the Australian New Zealand Clinical Trials Registry (ANZCTR)
