L2 Bio says that the FDA has approved a Phase 2b trial to evaluate the safety and efficacy of its L2-01 adipose-derived mesenchymal stem cell therapy (AD-MSC) for Crohn’s disease. From their website, it appears they are using expanded stem cells.
The trial will be double-blind, randomized, placebo-controlled, with 120 participants, and will take place across multiple sites.
According to L2, an important aspect of this trial is that the principal investigator will have the discretion to determine whether participants may continue with their current medications during the trial. Typically, these trials require patients to discontinue all other medications, but the FDA’s approval in this case is interesting as it allows physicians to exercise clinical judgment on the matter.
The company reports that using autologous stem cells (cells derived from the patient’s own body) or cells from a first-degree blood relative donor may significantly improve the safety profile of the procedure.
“L2 Bio firmly believes that if a drug has the potential to help the person with little or no contraindications, it should always be explored first. And that’s the position we want L2 to take in the fight against Crohn’s, Inflammatory Bowel Disease (IBD) and many other autoimmune disorders: first, do no harm, and to be utilized as the first option because of what we believe L2-01 offers is the highest safety profile in medicine,” said Vince Liguori, CEO of L2 Bio, LLC.
