A Double-Blind, Randomized, Placebo-Controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of L2-01 in Subjects With Crohn's Disease

L2-01 is a biological product consisting of human mesenchymal stem cells isolated from adipose tissue of the patient or a first-degree relative. The MSCs are expanded under Good Manufacturing Practice (GMP) conditions and suspended in 10 ml of lactated Ringer's solution. The product is administered as a single intravenous infusion at a dose of 1 × 10\^6 cells per kilogram of body weight, diluted in 100 ml of saline, infused over approximately 30 minutes. The infusion is closely monitored for safety.

Placebo consists of 10 ml of lactated Ringer's solution mixed with 100 ml of saline. It is administered as a single intravenous infusion over approximately 30 minutes. The placebo is packaged identically to the active product to maintain study blinding.