Shanghai LifeSci Initiates Global First Allogeneic Mesenchymal Stem Cell Therapy for IPF with Support from Academicians Wu Zuzhe and Jia Weiping

After overcoming numerous obstacles and years of dedicated effort, Shanghai Laifu Medical Technology Co., Ltd. (hereinafter referred to as “Shanghai Laifu Medical”) has successfully completed the development phase of its “Human Umbilical Cord Mesenchymal Stem Cell Injection.” The open-label clinical study titled “An Open-Label Clinical Study to Explore the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)” has been initiated at Shanghai Sixth People’s Hospital and will simultaneously commence at Zhongshan Hospital Affiliated to Fudan University and Shanghai Chest Hospital. This marks the official launch of the first registrational clinical trial worldwide for a Class 1 novel drug utilizing allogeneic umbilical cord mesenchymal stem cells for the treatment of idiopathic pulmonary fibrosis. Through collaborative efforts among all parties involved, it is anticipated that early exploratory studies, including safety observations and efficacy endpoints, will be completed promptly, paving the way for Phase III clinical trials.

At 10:00 a.m. on September 19, 2022, this clinical study was officially launched at Shanghai Sixth People’s Hospital. Academician Jia Weiping, head of the hospital’s Stem Cell Clinical Research Center, was invited to attend and extended congratulations to the project team. Following the ceremony, Academician Wu Zuoze, co-founder of Shanghai Laifu Medical, reviewed the project’s progress report. He encouraged the company’s R&D team and expressed high expectations for the project.

Academician Jia Weiping

Academician Jia Weiping, while encouraging the attending researchers and corporate representatives, also expressed her expectations for the clinical application of stem cells. She stated, “Stem cell drugs represent a completely new therapeutic approach in the new century, making it possible to cure certain intractable diseases.” During her tenure as President of Shanghai Sixth People’s Hospital, Academician Jia vigorously promoted the establishment of a filing center for stem cell clinical research, encouraged the implementation and execution of stem cell clinical research projects, and has been an active advocate in the field of stem cell clinical research.

Academician Wu Zuze

Academician Wu Zuze, hailed as the “Father of Stem Cells” in China, is a leading figure in the domestic stem cell research field. Academician Wu believes that the prospects for the development of clinical therapeutic products based on stem cells remain consistently promising across the sectors of industry, academia, research, and medicine. With the rapid implementation of this clinical study, Academician Wu highly praised the research team at Shanghai Laifu Medical, expressing his hope that its members will keep their mission in mind, stay true to their original aspirations, make continued efforts, and achieve even more remarkable accomplishments.

During the academic discussion session of the kick-off meeting, Professor Ren Tao, Director of the Department of Respiratory Medicine at Shanghai Sixth People’s Hospital and the principal investigator, briefly outlined the significant implications of the project for the treatment of idiopathic pulmonary fibrosis (IPF). IPF is a rare disease with a median survival time of only 2.5 years from diagnosis to death. Currently, there are no effective curative treatments available, and interventions can only slow disease progression. The "Human Umbilical Cord Mesenchymal Stem Cell Injection" developed by Shanghai Laifu Medical demonstrated superior outcomes compared to small-molecule positive control drugs in preclinical animal studies. It was shown to reduce inflammatory cell infiltration in lung tissue, significantly ameliorate pulmonary fibrosis, and exhibit low immunogenicity, holding promise for addressing this unmet clinical need.

Following the kickoff meeting, Academician Jia’s diabetes research team engaged in in-depth discussions with the stem cell R&D team at Shanghai Laifu Medical. Drawing on their respective prior research experience, the two teams exchanged views on the role of stem cells in endocrine diseases and ultimately reached a consensus that “stem cells hold potential for treating such complex diseases.”

Co-founders of Shanghai Laifu Medical: Academician Wu Zuoze (second from right), CEO Ms. Chen Baowen (first from left), and Professor Zheng Xinxiao (second from left)

Shanghai Laifu Medical Technology Co., Ltd. is a biopharmaceutical company dedicated to the integrated research, development, and scaled manufacturing of innovative cell and gene therapies (CGT). Founded in 2013 by entrepreneur Ms. Chen Baowen and Academician Wu Zuze of the Chinese Academy of Sciences, the company has assembled a team of world-renowned scientists to lead the independent R&D of innovative CGT drugs across multiple therapeutic areas, including oncology, the nervous system, the cardiovascular system, the endocrine system, and the immune system. The “Human Umbilical Cord Mesenchymal Stem Cell Injection” mentioned in this article took a total of six years from project initiation and product development to obtaining the Investigational New Drug (IND) approval.

Shanghai Sixth People’s Hospital has officially launched an open-label clinical study to explore the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF), marking the formal entry of this research into clinical trials and the commencement of participant recruitment.

Clinical Study Registration Information (Drug Clinical Trial Registration Platform)