FDA Approves Crohn's Disease Trial Utilizing Adipose-Derived Stem Cells

L2 Bio, FDA Approves Crohn's Disease Trial

as a Phase 2b Utilizing Adipose-Derived Stem Cells

FDA has approved an aggressive stem cell clinical trial, offering potential new relief through intravenous (IV) administration.

HENDERSON, Nev., May 13, 2025 /PRNewswire-PRWeb/ -- "We at L2 Bio thank the FDA for what we believe is a very aggressive approval in the fight against Crohn's Disease," states Vince Liguori, CEO of L2 Bio, LLC.

The FDA approval Is for a 120-person, multi-site, double-blind, randomized, placebo-controlled Phase IIb clinical trial to evaluate the safety and efficacy of L2-01 AD-MSCs in subjects with Crohn's Disease, with stem cells administered intravenously (IV). One of the reasons this approval is so significant is that the physician principal investigator (PI) will be able to determine if the subject can remain on current medications that may be offering some positive outcomes, as opposed to having the subject stop the use of all medications, which is more typical in a clinical trial. This is a strong positive reinforcement from the FDA in support of one of L2 Bio's core beliefs: that the "physician-patient relationship" and the doctor's right to "clinical autonomy" is the basis of good medicine.

Hippocrates, First, do no harm: "We at L2 Bio thank the FDA for what we believe is a very aggressive approval in the fight against Crohn's Disease," states Vince Liguori, CEO of L2 Bio, LLC.