NCT07010926Not 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
Source: ClinicalTrials.gov · Last updated 8 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 29 May 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- EL3 Bio, LLC.
- Diseases
- Crohn's disease
- NCT number
- NCT07010926
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 15 Aug 2025 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Patient had major surgery or serious trauma within 6 weeks before enrolment.
- Patients who are receiving or have received another investigational drug within 30 days prior to the first visit.
Other illness
- 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 who tested positive for HIV 1/2, HBV, HCV, HTLV I/II, WNV, and syphilis
Other
- Subjects with congenital or acquired immunodeficiency.
- Flu symptoms
- Pregnant or breastfeeding women.
- Physical or psychological impossibility of following the protocol requirements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.