A new clinical trial is set to investigate systemic infusions of allogeneic mesenchymal stromal cells harvested from adipose tissue as a promising treatment for severe systemic sclerosis (SSc). The study is not yet recruiting.
The researchers seek 6 healthy volunteers to donate 40 to 60 g of fat tissue during planned abdominal liposuction or lipoaspiration performed under general anesthetic and usual care. Participants must be nonsmoking adults with a body mass index under 30.
Those diagnosed with various diseases and infections, a history of central nervous system surgeries, as well as pregnant women and people treated with extractive pituitary hormones, steroids (for more than 5 days in the past 3 months), and lithium will not be eligible for the study. Exclusion criteria also cite multiple sexual partners between the donor or his or her usual partner, intravenous addiction of the donor or regular partner, and accidental exposure to blood or derivatives suspected of being contaminated.
The researchers will analyze the production of at least 3 batches of mesenchymal stromal cells derived from donor adipose tissue for up to 2 months as the primary outcome measure. The secondary outcome measures include the percentage of viability, and expression of HLA-DR, as well as CD73+ cells, CD90+ cells, and CD105+ cells within a time frame of 2 months.
Read more about SSc experimental therapies
“Mesenchymal stromal cells represent a promising therapeutic approach for SSc. We previously a) showed disease-specific abnormalities in mesenchymal stromal cells harvested from the bone marrow of SSc patients, providing a strong rationale to use allogeneic mesenchymal stromal cells to treat SSc patients, b) completed the first phase 1/2 dose escalation trial using allogenic mesenchymal stromal cells harvested from bone marrow infusion in 20 severe SSc patients with no safety issues, significant improvement in skin fibrosis at 3 to 6 months after infusion which appeared lower thereafter, thereby supporting the need for repeated infusions,” the researchers wrote.
The study, sponsored by Assistance Publique – Hôpitaux de Paris, is set to be completed by February 2025.
Manufacturing of allogeneic adipose tissue-derived mesenchymal stromal cells for treatment of severe systemic sclerosis. ClinicalTrials.gov. Published July 17, 2023. Accessed July 31, 2023.