SMSbiotech has announced a significant milestone in its pursuit of its regenerative medicine technology, securing approval to commence a Phase I clinical trial in Australia (registration number: ANZCTR12624001140549p). The trial will focus on evaluating the safety and tolerability of the company's innovative Small Mobile stem (SMS) cell therapy for Chronic Obstructive Pulmonary Disease (COPD).
This development marks a crucial step forward in SMSbiotech's efforts to address this debilitating respiratory condition. The Phase I trial, conducted in Australia, will be the first human trial of this specific cell therapy.
"This is a very important milestone for our company," said Dr. Abdulkader Rahmo, President and Chief Scientific Officer of SMSbiotech, Inc. "Receiving approval to begin our Phase I clinical trial in Australia is a testament to the hard work and dedication of our research team exploring a novel stem cell with unique characteristics. We are eager to begin this trial and gather long-awaited human data that we hope will lead to an expedited new treatment option for those suffering from COPD."
COPD is a progressive lung disease that gradually impairs breathing, with current treatments primarily focused on symptom management and slowing disease progression rather than reversing damage. While no widely available therapies can fully restore lung function, emerging research, including SMSbiotech's innovative SMS stem cell technology, aims to regenerate damaged alveolar lung tissue. This approach represents a potential breakthrough in disease-modifying therapy by targeting the underlying tissue damage and offering the possibility of functional lung restoration.
The Phase I trial will primarily assess the safety and tolerability of the therapy in human subjects. The study will enroll 18 patients with mild to moderate COPD in accordance with the patient enrollment criteria outlined by the US FDA. Subsequent phases of clinical trials will then evaluate the treatment’s efficacy.
This announcement is particularly relevant for those interested in advancements in regenerative medicine, as well as individuals following new potential treatments for COPD.
About SMSbiotech:
SMSbiotech is a regenerative medicine company located in San Diego, CA, USA, dedicated to developing innovative stem cell therapies for a range of debilitating diseases.
Forward-Looking Statements
This press release contains forward-looking statements that are based on our current expectations forecasts, and assumptions. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to, the success of our clinical trials, the regulatory approval process, and the commercialization of our therapies.
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View source version on businesswire.com: https://www.businesswire.com/news/home/20250318995283/en/
Contact details:
Abdulkader Rahmo
President and CSO
a.rahmo@smsbiotech.com
657-203-3030
Jason Kirkness
Global Clinical Program Lead - Respiratory
j.kirkness@smsbiotech.com
