Crohn&Amp;#39;sPhase 2NCT07010926
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
A Phase 2 study testing L2-01 adipose-derived mesenchymal stem cells (MSC) in people with Crohn&Amp;#39;s and Crohn&Amp;#39;s Disease (CD), run by EL3 Bio, LLC..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn&Amp;#39;s, Crohn&Amp;#39;s Disease (CD)
- What is being tested?
- L2-01 adipose-derived mesenchymal stem cells (MSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- 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.
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- Subjects with congenital or acquired immunodeficiency.
- Subjects who tested positive for HIV 1/2, HBV, HCV, HTLV I/II, WNV, and syphilis
- Flu symptoms
- Patient had major surgery or serious trauma within 6 weeks before enrolment.
- Pregnant or breastfeeding women.
- Physical or psychological impossibility of following the protocol requirements
- Patients who are receiving or have received another investigational drug within 30 days prior to the first visit.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
This Phase II clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of L2-01, a human adipose-derived mesenchymal stem cell (MSC) product, in patients with Crohn's Disease (CD). L2-01 consists of MSCs harvested from the patient's own adipose tissue or that of a first-degree relative, expanded in culture, and administered as a single intravenous infusion at a dose of 1 × 10^6 cells per kilogram of body weight.
The study enrolls 120 adult subjects with non-active Crohn's Disease, defined by a Crohn's Disease Activity Index (CDAI) of 200 or less. Patients are randomized in a 1:1 ratio to receive either L2-01 or placebo (sterile normal saline). The initial 20 patients are enrolled in a staggered manner to closely monitor safety signals, followed by enrollment of an additional 100 subjects if no significant adverse drug reactions are observed.
Subjects undergo liposuction to collect approximately 25 ml of lipoaspirate from the lower abdomen or flanks under local anesthesia. The MSCs are isolated, expanded under Good Manufacturing Practice (GMP) conditions, cryopreserved, and then thawed and prepared as a ready-to-infuse suspension prior to administration. Placebo infusions contain an identical volume of lactated Ringer's solution mixed with saline, maintaining blinding integrity.
The infusion is administered intravenously over approximately 30 minutes with close monitoring for adverse events, vital sign changes, and infusion reactions during and after the procedure. Safety assessments include monitoring treatment-emergent adverse events (TEAEs), laboratory tests (including comprehensive metabolic panel, complete blood count, coagulation studies, and inflammatory markers), physical examinations, vital signs, and adverse event reporting per MedDRA coding.
Efficacy assessments focus on changes in systemic disease activity, inflammatory markers, imaging (pelvic MRI), and quality of life metrics (using the IBDQ-32 questionnaire). Follow-up visits occur at scheduled intervals up to 24 weeks post-infusion to assess both safety and therapeutic effects.
Quality assurance for the study includes routine source data verification by the Contract Research Organization (CRO) monitors, adherence to International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and oversight by an independent Data Safety Monitoring Board (DSMB) composed of physicians and regulatory experts who review safety data in real time. Investigational product handling, storage, and accountability procedures are strictly controlled and documented.
Statistical analyses are primarily descriptive with 95% confidence intervals, focusing on safety endpoints in the intent-to-treat (ITT) population. No formal interim analyses are planned; however, stopping rules are predefined for severe adverse events or safety concerns related to the investigational product or procedures. The study aims to provide clinically meaningful data to support further development of L2-01 as a novel immunomodulatory therapy for Crohn's Disease.
- Conditions
- Crohn&Amp;#39;s, Crohn&Amp;#39;s Disease (CD)
- Being tested
- L2-01 adipose-derived mesenchymal stem cells (MSC), Placebo saline solution
- Keywords
- Crohn's Disease, Stem Cells, Autologous, Mesenchymal Stem Cells (MSC), Adipose, Crohn's
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 100 ml of saline, infused over approximately 30 minutes. The infusion is closely monitored for safety.
Placebo saline solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| L2-01 Treatment Arm | Experimental | Participants in this arm receive a single intravenous infusion of L2-01, a human adipose-derived mesenchymal stem cell product. The dose is 1 × 10^6 MSC cells per kilogram of body weight, suspended in 10 ml of lactated Ringer's solution mixed with 100 ml of saline. The infusion is administered over approximately 30 minutes. MSCs are derived from the patient's own adipose tissue or from that of a first-degree relative. Receives: Biological: L2-01 adipose-derived mesenchymal stem cells (MSC) |
| Placebo Comparator Arm | Placebo comparator | Participants in this arm receive a single intravenous infusion of placebo, consisting of 10 ml of lactated Ringer's solution mixed with 100 ml of saline. The infusion is administered over approximately 30 minutes. The placebo product is packaged identically to the active product to maintain study blinding. Receives: Other: Placebo saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events occurring in less than 5% of study participants as a measure of safety.
Measured: From the day of infusion through 12 weeks post-infusion.
Secondary outcomes (5)
Change in Crohn's Disease Activity Index (CDAI) from baseline to 12 weeks post-infusion.
Measured: Baseline and 12 weeks post-infusion.
Improvement in inflammatory markers and MRI results from baseline to 12 weeks post-infusion.
Measured: Baseline and 12 weeks post-infusion.
Change in quality of life as assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ-32) from baseline to 12 weeks post-infusion.
Measured: Baseline and 12 weeks post-infusion.
Relapse rate among patients who achieved treatment success with adipose-derived mesenchymal stem cells.
Measured: Up to 24 weeks post-infusion.
Biological characterization of the cell product (phenotype study, suppressor capacity, cytokine production) and its correlation with therapeutic effect.
Measured: At infusion and during follow-up assessments up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn&Amp;#39;sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EL3 Bio, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FDAMap, Akan Biosciences, LLC
- Responsible party
- Sponsor
- Investigators
- Mukesh Kumar, PhD, RAC, Study director, FDAMap
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010926
- Sponsor's protocol ID
- L2-01-CD
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- L2-01-CD
- Conditions
- Crohn&Amp;#39;s, Crohn&Amp;#39;s Disease (CD)
- Keywords
- Crohn's Disease, Stem Cells, Autologous, Mesenchymal Stem Cells (MSC), Adipose, Crohn's
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- EL3 Bio, LLC.Industry (pharma, biotech, devices)
- Collaborators
- FDAMap, Akan Biosciences, LLC
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase II clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of L2-01, a human adipose-derived mesenchymal stem cell (MSC) product, in patients with Crohn's Disease (CD). L2-01 consists of MSCs harvested from the patient's own adipose tissue or that of a first-degree relative, expanded in culture, and administered as a single intravenous infusion at a dose of 1 × 10^6 cells per kilogram of body weight.
The study enrolls 120 adult subjects with non-active Crohn's Disease, defined by a Crohn's Disease Activity Index (CDAI) of 200 or less. Patients are randomized in a 1:1 ratio to receive either L2-01 or placebo (sterile normal saline). The initial 20 patients are enrolled in a staggered manner to closely monitor safety signals, followed by enrollment of an additional 100 subjects if no significant adverse drug reactions are observed.
Subjects undergo liposuction to collect approximately 25 ml of lipoaspirate from the lower abdomen or flanks under local anesthesia. The MSCs are isolated, expanded under Good Manufacturing Practice (GMP) conditions, cryopreserved, and then thawed and prepared as a ready-to-infuse suspension prior to administration. Placebo infusions contain an identical volume of lactated Ringer's solution mixed with saline, maintaining blinding integrity.
The infusion is administered intravenously over approximately 30 minutes with close monitoring for adverse events, vital sign changes, and infusion reactions during and after the procedure. Safety assessments include monitoring treatment-emergent adverse events (TEAEs), laboratory tests (including comprehensive metabolic panel, complete blood count, coagulation studies, and inflammatory markers), physical examinations, vital signs, and adverse event reporting per MedDRA coding.
Efficacy assessments focus on changes in systemic disease activity, inflammatory markers, imaging (pelvic MRI), and quality of life metrics (using the IBDQ-32 questionnaire). Follow-up visits occur at scheduled intervals up to 24 weeks post-infusion to assess both safety and therapeutic effects.
Quality assurance for the study includes routine source data verification by the Contract Research Organization (CRO) monitors, adherence to International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and oversight by an independent Data Safety Monitoring Board (DSMB) composed of physicians and regulatory experts who review safety data in real time. Investigational product handling, storage, and accountability procedures are strictly controlled and documented.
Statistical analyses are primarily descriptive with 95% confidence intervals, focusing on safety endpoints in the intent-to-treat (ITT) population. No formal interim analyses are planned; however, stopping rules are predefined for severe adverse events or safety concerns related to the investigational product or procedures. The study aims to provide clinically meaningful data to support further development of L2-01 as a novel immunomodulatory therapy for Crohn's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| L2-01 Treatment Arm | Experimental | Biological: L2-01 adipose-derived mesenchymal stem cells (MSC)Participants in this arm receive a single intravenous infusion of L2-01, a human adipose-derived mesenchymal stem cell product. The dose is 1 × 10^6 MSC cells per kilogram of body weight, suspended in 10 ml of lactated Ringer's solution mixed with 100 ml of saline. The infusion is administered over approximately 30 minutes. MSCs are derived from the patient's own adipose tissue or from that of a first-degree relative. |
| Placebo Comparator Arm | Placebo comparator | Other: Placebo saline solutionParticipants in this arm receive a single intravenous infusion of placebo, consisting of 10 ml of lactated Ringer's solution mixed with 100 ml of saline. The infusion is administered over approximately 30 minutes. The placebo product is packaged identically to the active product to maintain study blinding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | L2-01 Treatment Arm |
| Placebo saline solutionPlacebo 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. | Other | Placebo Comparator Arm |
Primary outcome
Incidence of adverse events occurring in less than 5% of study participants as a measure of safety.
Time frame: From the day of infusion through 12 weeks post-infusion.
5 secondary outcomes
Change in Crohn's Disease Activity Index (CDAI) from baseline to 12 weeks post-infusion.
Time frame: Baseline and 12 weeks post-infusion.
Improvement in inflammatory markers and MRI results from baseline to 12 weeks post-infusion.
Time frame: Baseline and 12 weeks post-infusion.
Change in quality of life as assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ-32) from baseline to 12 weeks post-infusion.
Time frame: Baseline and 12 weeks post-infusion.
Relapse rate among patients who achieved treatment success with adipose-derived mesenchymal stem cells.
Time frame: Up to 24 weeks post-infusion.
Biological characterization of the cell product (phenotype study, suppressor capacity, cytokine production) and its correlation with therapeutic effect.
Time frame: At infusion and during follow-up assessments up to 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mukesh Kumar, PhD, RAC study director
FDAMap
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L2-01 adipose-derived mesenchymal stem cells (MSC) in people with Crohn&Amp;#39;s and Crohn&Amp;#39;s Disease (CD), run by EL3 Bio, LLC..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vince Liguori (847-561-0217, vince@agebiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events occurring in less than 5% of study participants as a measure of safety. (time frame: From the day of infusion through 12 weeks post-infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.