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NCT07010926
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 trial testing L2-01 adipose-derived mesenchymal stem cells (MSC) in Crohn&Amp;#39;s in 120 participants. Not yet recruiting.
31 December 2026
Quick facts
| Lead sponsor | L2 Bio, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 15 August 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
Drugs / interventions tested
- L2-01 adipose-derived mesenchymal stem cells (MSC) — full drug profile →
- Placebo saline solution
Conditions studied
- Crohn&Amp;#39;s — all drugs for Crohn&Amp;#39;s →
- Crohn&Amp;#39;s Disease (CD) — all drugs for Crohn&Amp;#39;s Disease (CD) →
Sponsor
L2 Bio, LLC — full company profile →
Who can join
18 and older, any sex, with Crohn&Amp;#39;s or Crohn&Amp;#39;s Disease (CD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07010926
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07010926 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by L2 Bio, LLC
- Last refreshed: 8 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07010926.
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