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
Phase 2 · Testing L2-01 adipose-derived mesenchymal stem cells (MSC) · Sites not listed yet · L2 Bio, LLC
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing L2-01 adipose-derived mesenchymal stem cells (MSC) (a biologic) as a possible treatment. Condition(s) listed: Crohn&Amp;#39;s and Crohn&Amp;#39;s Disease (CD).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2025-08-15 (planned).
- Main results expected around 2026-12-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Incidence of adverse events occurring in less than 5% of study participants as a measure of safety. (From the day of infusion through 12 weeks post-infusion.)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn&Amp;#39;s; Crohn&Amp;#39;s Disease (CD) |
| Lead sponsor | L2 Bio, LLC |
| Collaborators | FDAMap; Akan Biosciences, LLC |
| Enrollment | 120 (estimated) |
| Start date | 2025-08-15 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2025-06-08 |
| Last updated | 2025-06-08 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07010926 |
Interventions
- L2-01 adipose-derived mesenchymal stem cells (MSC) (Biological)
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… - Placebo saline solution (Other)
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.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. 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) 2. Any gender, > 18 Years of age 3. Negative pregnancy test in female subjects 4. Patients voluntarily sign the informed consent before performance of any study-related procedures 5. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements Exclusion Criteria: 1. Patients who have received infliximab or any other anti-TNF agent within 8 weeks before the cell treatment administration. 2. Patients who have received tacrolimus or cyclosporine within 4 weeks before cell treatment. 3. Patients with a history of alcohol or other addictive substance abuse within 6 months before inclusion. 4. Severe uncontrolled diseases (chronic renal failure, cardio, pulmonary, etc.). 5. Any type of medical or psychiatric disease which are considered an exclusion criterion, in the investigator's opinion. 6. 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. 7. Subjects with congenital or acquired immunodeficiency. 8. Subjects who tested positive for HIV 1/2, HBV, HCV, HTLV I/II, WNV, and syphilis 9. Flu symptoms 10. Patient had major surgery or serious trauma within 6 weeks before enrolment. 11. Pregnant or breastfeeding women. 12. Physical or psychological impossibility of following the protocol requirements 13. Patients who are receiving or have received another investigational drug within 30 days prior to the first visit.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.