A Double-Blind, Randomized, Placebo-Controlled Phase II Clinical Trial to Evaluate the Safety and… (NCT07010926) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
120 participantsStarted 2025-08-15
Plain-language summary
This clinical trial is testing a new treatment called L2-01 in patients with Crohn's Disease, a condition that causes ongoing inflammation of the digestive tract. Current treatments for Crohn's Disease do not work for everyone, and some patients still experience symptoms even with standard therapies.
The purpose of this study is to determine if a single intravenous infusion of L2-01, which uses cells called mesenchymal stem cells derived from a patient's own or their close relative's body fat, is safe and can help improve symptoms of Crohn's Disease. Researchers will compare the effects of L2-01 to a placebo (an inactive substance) to see if L2-01 helps reduce inflammation and improves quality of life in patients.
The main questions the study aims to answer are:
Is L2-01 safe for patients with Crohn's Disease?
Can L2-01 effectively reduce symptoms and improve the health of people living with Crohn's Disease compared to a placebo?
The researchers believe that L2-01 will be safe and more effective than placebo in reducing inflammation, decreasing disease activity, and improving patients' quality of life.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with Crohn Disease (CD) diagnosed within 12 months before acceptance of clinical, endoscopical, anatomopathological and/or radiological criteria and have a non-active CD. (Crohn´s Disease Activity Index (CDAI)≤ 200)
✓. Any gender, \> 18 Years of age
✓. Negative pregnancy test in female subjects
✓. Patients voluntarily sign the informed consent before performance of any study-related procedures
✓. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
Exclusion criteria
✕. Patients who have received infliximab or any other anti-TNF agent within 8 weeks before the cell treatment administration.
✕. Patients who have received tacrolimus or cyclosporine within 4 weeks before cell treatment.
✕. Patients with a history of alcohol or other addictive substance abuse within 6 months before inclusion.
✕
What they're measuring
1
Incidence of adverse events occurring in less than 5% of study participants as a measure of safety.
Timeframe: From the day of infusion through 12 weeks post-infusion.
. Severe uncontrolled diseases (chronic renal failure, cardio, pulmonary, etc.).
✕. Any type of medical or psychiatric disease which are considered an exclusion criterion, in the investigator's opinion.
✕. Patients with a diagnosis of malignant neoplasia, except basal cell or epidermoid carcinoma of the skin, or a previous history of malignant tumors, except those that have no evidence of relapse for at least 5 years.
✕. Subjects with congenital or acquired immunodeficiency.
✕. Subjects who tested positive for HIV 1/2, HBV, HCV, HTLV I/II, WNV, and syphilis