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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

NCT07010926 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • Crohn&Amp;#39;s
  • Crohn&Amp;#39;s Disease (CD)

Interventions

BIOLOGICAL

L2-01 adipose-derived mesenchymal stem cells (MSC)

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.

OTHER

Placebo saline solution

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.

Sponsors & Collaborators

  • FDAMap

    collaborator UNKNOWN

  • Akan Biosciences, Inc.

    collaborator UNKNOWN

  • L2 Bio, LLC

    lead INDUSTRY

Principal Investigators

  • Mukesh Kumar, PhD, RAC · FDAMap

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010926 on ClinicalTrials.gov