A new phase 1 clinical trial exploring the safety and tolerability of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF) is now open.
The interventional, open-label trial aims to recruit 18 patients with IPF aged 50 to 75 years in China. Participants will be divided into 4 groups, and those in each group will receive a different dose.
The primary outcome measures of the trial will be the patients’ tolerance to the stem cell injection from the first administration to 4 weeks after the administration as well as the dose exploration of the treatment.
The secondary outcome measure is the preliminary efficacy evaluated through changes from baseline in St. George’s respiratory questionnaire, dyspnea score, cough score, and 6-minute walk test as well as changes from baseline in lung function as measured by forced vital capacity and the diffusing capacity of carbon monoxide.
Other outcome measures include the preliminary efficacy evaluated through changes from baseline in chest high-resolution computed tomography scores and lung tumor markers, as well as the frequency and severity of acute exacerbations of IPF. The immunogenicity of the cells will also be evaluated through changes in specific immunoglobulin G and cytokines from baseline.
Read more about the symptoms of IPF
The trial is not yet open for recruitment. It is expected to start this month and be completed in August 2025.
IPF is a rare, chronic, and progressive disease of unknown etiology characterized by the buildup of fibrotic tissue in the pulmonary parenchyma. There is currently no cure for the disease, and treatment options mainly focus on managing the symptoms.
Mesenchymal stem cells may play a critical role in lung repair, and researchers have been working on their potential for the treatment of IPF. However, the approach remains controversial due to the involvement of these stem cells in cellular senescence and tissue aging processes.
Phase I/IIa clinical trial of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF). ClinicalTrials.gov. July 21, 2022. Updated August 1, 2022. Accessed August 5, 2022.