Ulcerative ColitisPhase 1/2UCNCT04543994
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)
A Phase 1/2 study testing Remestemcel-L in people with Ulcerative Colitis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Remestemcel-L
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2020to 15 Nov 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females 18-75 years of age.
- Ulcerative colitis of at least 6 months duration with medically refractory symptoms
- Exposure to corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 4 weeks for any monoclonal antibody is necessary.
- If receiving conventional immunomodulators (ie, AZA, 6-MP, or MTX), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks.
- If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks.
- If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks.
Show all 24Show fewer
- If receiving oral corticosteroids, the dose must be ≤20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks.
- If receiving budesonide, the dose must have been stable for at least 2 weeks.
- If oral 5-ASA compounds or oral corticosteroids (including budesonide) have been recently discontinued, they must have been stopped for at least 2 weeks.
- The following medications/therapies must have been discontinued before first administration of study agent:
- TNF-antagonist therapy (eg, infliximab, etanercept, certolizumab, adalimumab, golimumab), vedolizumab, ustekinumab for at least 4 weeks.
- Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks.
- 6-thioguanine (6-TG) must have been discontinued for at least 4 weeks.
- Rectal corticosteroids (ie, corticosteroids [including budesonide] administered to the
- rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks.
- Rectal 5-ASA compounds (ie, 5-ASAs administered to the rectum or sigmoid colon viafoam or enema or suppository) for at least 2 weeks.
- Parenteral corticosteroids for at least 2 weeks.
- Total parenteral nutrition (TPN) for at least 2 weeks.
- Antibiotics for the treatment of UC (eg, ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks.
- No colonic dysplasia and malignancy as ruled out by colonoscopy within 30 days of MSC delivery
- Ability to comply with protocol
- Competent and able to provide written informed consent
- Must have lost response to at least one monoclonal antibody (anti-TNF, anti-interleukin, or anti-integrin therapy), tofacitinib, or have a contra-indication to biologic therapy
- If patient is of reproductive capacity, willing to use adequate birth control measures while they are in the study
Who cannot join
- Inability to give informed consent.
- Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- Specific exclusions;
- HIV
- Hepatitis B or C
- Abnormal AST or ALT at screening defined as AST >100 or ALT > 100
Show all 47Show fewer
- Abnormal basic laboratory values with the following cut-offs:
- Alkaline phosphate >200
- WBC >13
- Hemoglobin <7
- Platelets <50 or > 1 million
- Creatinine >1.5
- History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
- Investigational drug within one year of study enrollment
- Pregnant or breast feeding.
- Fulminant colitis requiring emergency surgery
- Concurrent active clostridium difficile infection of the colon
- Concurrent CMV infection of the colon
- Evidence of colonic perforation
- Massive hemorrhage from the colon requiring emergent surgery
- Crohn's colitis or indeterminate colitis
- Microscopic, ischemic or infectious colitis
- Neoplasia of the colon and preoperative biopsy
- Presence of an ostomy
- Prior small bowel resection
- Previous colonic resection
- Colonic stricture that unable to pass an adult colonoscope
- Active or latent tuberculosis
- Unable to wean off corticosteroids
- Patients with extra colonic ulcerative colitis including primary sclerosing cholangitis
- Patients with history of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 90 days of study entry
- Patients with known allergy to local anesthetics
- Patients with a known allergy to DMSO, porcine and/or bovine proteins
- Patients taking anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix) to reduce the risk of bleeding/ hemarthrosis
- If patient is of reproductive capacity, unwilling to use adequate birth control measures while they are in the study
- Control patients will have additional criteria that need to be met prior to the patients crossing over to receive treatment.
- Inclusion Criteria for control patients prior to entering the treatment phase:
- Received placebo at the point of first injection
- Completed all study visits to date
- Clinical status has remained the same or improved, not worsened
- Exclusion Criteria for control patients who will be entering the treatment phase:
- Required repeat hospitalization for a colitis flare
- Given oral and intravenous steroids for a colitis flare
- Had worsening abdominal pain frequency of bowel movements, blood in stool
- Desires exclusion from the study to pursue escalation in medical management or surgery Allogeneic Bone
- Has a colonic perforation that requires surgery
- Has colonic bleeding that requires surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IB/IIA Study of Remestemcel-L, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product, for the Treatment of Medically Refractory Ulcerative Colitis
The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory ulcerative colitis.
This study will enroll adult patients with medically refractory ulcerative colitis who are planning to switch biologic therapy or undergo colectomy as the next stage in their treatment plan.
Read the detailed description
Ulcerative colitis (UC) is an idiopathic chronic inflammatory disease of the colon and rectum, which continues to increase in incidence for unknown reasons, resulting in a significant burden to the healthcare system. UC is characterized by persistent mucosal inflammation of the colon and rectum with a chronic remitting and relapsing behavior which leaves patients on chronic immunosuppression and hospitalizations to treat the disease symptoms, but unable to cure the disease. Despite the ever-growing armamentarium of immunosuppressive medication, up to 30% of patients still require a colectomy for medically refractory disease.
Participants with medically refractory ulcerative colitis will be treated by targeted endoscopic delivery of remestemcel-L, an ex vivo culture expanded allogeneic bone marrow derived mesenchymal stem cell product at a dose of 150 or 300 million. This will be injected into the submucosal layer of the colon and rectal wall.
Patients will receive a second dose of remestemcel-L at a dose of 150 or 300 million MSCs (same dose as initial). If at 3 months post injection of remestemcel-L there is clinical remission, escalation of medical management and/or surgery will be delayed and patients observed. If there is worsening or no improvement in treated patients, then patients will proceed with escalation of medical management or colectomy as per standard of care. Control patients without improvement will cross over to receive remestemcel-L at 3 months and may be retreated at 6 months. All patients will be followed for two years post initial treatment.
There will be a total of 4 cohorts of 3 patients (2 treatment:1 control) receiving the 150 million MSC dose of study drug and a total of 4 cohorts of 3 patients (2 treatment:1 control) receiving 300 million MSCs dose of study drug. This study plans to enroll a total of 24 participants.
The primary endpoint of this study is to determine the safety and feasibility of endoscopic injection of remestemcel-L, an ex vivo culture expanded allogeneic bone marrow derived mesenchymal stem cell product for treatment of medically refractory ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Remestemcel-L, Placebo
- Keywords
- Ulcerative Colitis, medically refractory ulcerative colitis, UC, refractory ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remestemcel-LDrug
An ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis
Remestemcel-LDrug
An ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Remestemcel-L (150 million cells) | Experimental | Targeted endoscopic delivery of remestemcel-L at a dose of 150 million cells into the submucosal layer of the colon wall at baseline.
If at 3 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 150 million MSCs (same dose at initial). Receives: Drug: Remestemcel-L |
| Remestemcel-L (300 million cells) | Experimental | Targeted endoscopic delivery of remestemcel-L at a dose of 300 million cells into the submucosal layer of the colon wall at baseline.
If at 3 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 300 million MSCs (same dose at initial). Receives: Drug: Remestemcel-L |
| Placebo | Placebo comparator | Direct injection of normal saline into the submucosal layer of the colon wall.
If not completely healed after 3 months, participants will then cross over to the treatment group to receive a direct injection of remestemcel-L at a dose of 150 or 300 million cells into the submucosal layer of the colon wall.
If at 6 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 150 or 300 million MSCs (same dose at initial). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related adverse events
Number of participants with treatment related adverse events post-injection of 150 or 300 million allogeneic bone marrow derived mesenchymal stem cells for the treatment of medically refractory Ulcerative colitis as assessed by protocol CCF-Stem Cells IBD-005.
Measured: Month 3
Secondary outcomes (5)
Clinical and endoscopic remission
Number of participants with clinical and endoscopic remission post-injection of 150 or 300 million bone marrow allogeneic derived mesenchymal stem cells for the treatment of medically refractory Ulcerative colitis.
Clinical and endoscopic remission is defined as:
Clinical remission: Mayo Clinic score of 2 or lower and no subscore higher than 1, and mucosal healing, defined as an endoscopic subscore of 0 or 1
Endoscopic remission: Mayo Clinic scale endoscopic subscore of 0 or 1
Measured: Month 3, Month 12
Clinical and endoscopic response
Number of participants with a clinical and endoscopic response post-injection of 150 or 300 million allogeneic bone marrow derived mesenchymal stem cells for the treatment of medically refractory Ulcerative colitis.
Clinical and endoscopic response is defined as:
Clinical response: Reduction in the Mayo Clinic score by 3 points and a decrease of at least 30% from the baseline score with a decrease of at least 2 points on the rectal bleeding subscale to an absolute rectal bleeding score of 1 or 2.
Endoscopic response: Mayo Clinic scale endoscopic subscore decrease by at least one point
Measured: Month 3, Month 12
Partial clinical and endoscopic response
Number of participants with a partial clinical and endoscopic response post-injection of 150 or 300 million allogeneic bone marrow derived mesenchymal stem cells for the treatment of medically refractory Ulcerative colitis.
Partial clinical and endoscopic response is defined as:
Partial clinical response: Reduction in the Mayo Clinic score that does not meet the following: by 3 points and a decrease of at least 30% from the baseline score with a decrease of at least 2 points on the rectal bleeding subscale to an absolute rectal bleeding score of 1 or 2
Partial endoscopic response: No improvement in Mayo Clinic scale endoscopic subscore that stays the same or decreases
Measured: Month 3, Month 12
Lack of response
Number of participants with a lack of response post-injection of 150 or 300 million allogeneic bone marrow derived mesenchymal stem cells for the treatment of medically refractory Ulcerative colitis.
Lack of response is defined as:
Clinical response: No improvement in Mayo Clinic score
Endoscopic response: No improvement or worsening in Mayo Clinic scale endoscopic subscore
Measured: Month 3, Month 12
Mayo clinic score
Mayo clinic score will be used to measure quality of life in participants.
*Score ranges from 0 (least severe) to 12(most severe).
Measured: Month 1 through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start10 Nov 2020
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Why it stopped: PI left Cleveland Clinic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Mesoblast, Inc.
- Responsible party
- Principal investigator, Anthony Lembo, The Cleveland Clinic
- Investigators
- Amy Lightner, Principal investigator, Cleveland Clinic Foundation, Cleveland OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543994
- Sponsor's protocol ID
- 20-1005
- Acronym
- UC
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2020
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739.
PubMed 23964933Kin C, Kate Bundorf M. As Infliximab Use for Ulcerative Colitis Has Increased, so Has the Rate of Surgical Resection. J Gastrointest Surg. 2017 Jul;21(7):1159-1165. doi: 10.1007/s11605-017-3431-0. Epub 2017 May 8.
PubMed 28484890
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/IIA Study of Remestemcel-L, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product, for the Treatment of Medically Refractory Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04543994
- Acronym / sponsor ID
- UC / 20-1005
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, medically refractory ulcerative colitis, UC, refractory ulcerative colitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left Cleveland Clinic
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Mesoblast, Inc.
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 10 Sep 2020 (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.
The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory ulcerative colitis.
This study will enroll adult patients with medically refractory ulcerative colitis who are planning to switch biologic therapy or undergo colectomy as the next stage in their treatment plan.
Detailed description
Ulcerative colitis (UC) is an idiopathic chronic inflammatory disease of the colon and rectum, which continues to increase in incidence for unknown reasons, resulting in a significant burden to the healthcare system. UC is characterized by persistent mucosal inflammation of the colon and rectum with a chronic remitting and relapsing behavior which leaves patients on chronic immunosuppression and hospitalizations to treat the disease symptoms, but unable to cure the disease. Despite the ever-growing armamentarium of immunosuppressive medication, up to 30% of patients still require a colectomy for medically refractory disease.
Participants with medically refractory ulcerative colitis will be treated by targeted endoscopic delivery of remestemcel-L, an ex vivo culture expanded allogeneic bone marrow derived mesenchymal stem cell product at a dose of 150 or 300 million. This will be injected into the submucosal layer of the colon and rectal wall.
Patients will receive a second dose of remestemcel-L at a dose of 150 or 300 million MSCs (same dose as initial). If at 3 months post injection of remestemcel-L there is clinical remission, escalation of medical management and/or surgery will be delayed and patients observed. If there is worsening or no improvement in treated patients, then patients will proceed with escalation of medical management or colectomy as per standard of care. Control patients without improvement will cross over to receive remestemcel-L at 3 months and may be retreated at 6 months. All patients will be followed for two years post initial treatment.
There will be a total of 4 cohorts of 3 patients (2 treatment:1 control) receiving the 150 million MSC dose of study drug and a total of 4 cohorts of 3 patients (2 treatment:1 control) receiving 300 million MSCs dose of study drug. This study plans to enroll a total of 24 participants.
The primary endpoint of this study is to determine the safety and feasibility of endoscopic injection of remestemcel-L, an ex vivo culture expanded allogeneic bone marrow derived mesenchymal stem cell product for treatment of medically refractory ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remestemcel-L (150 million cells) | Experimental | Drug: Remestemcel-LTargeted endoscopic delivery of remestemcel-L at a dose of 150 million cells into the submucosal layer of the colon wall at baseline. If at 3 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 150 million MSCs (same dose at initial). |
| Remestemcel-L (300 million cells) | Experimental | Drug: Remestemcel-LTargeted endoscopic delivery of remestemcel-L at a dose of 300 million cells into the submucosal layer of the colon wall at baseline. If at 3 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 300 million MSCs (same dose at initial). |
| Placebo | Placebo comparator | Other: PlaceboDirect injection of normal saline into the submucosal layer of the colon wall. If not completely healed after 3 months, participants will then cross over to the treatment group to receive a direct injection of remestemcel-L at a dose of 150 or 300 million cells into the submucosal layer of the colon wall. If at 6 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 150 or 300 million MSCs (same dose at initial). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Males and Females 18-75 years of age.
- Ulcerative colitis of at least 6 months duration with medically refractory symptoms
- Exposure to corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 4 weeks for any monoclonal antibody is necessary.
- The following medications/therapies must have been discontinued before first administration of study agent:
- No colonic dysplasia and malignancy as ruled out by colonoscopy within 30 days of MSC delivery
Key exclusion criteria (47 listed)
- Inability to give informed consent.
- Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- Specific exclusions;
- Abnormal AST or ALT at screening defined as AST >100 or ALT > 100
- Abnormal basic laboratory values with the following cut-offs:
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 |
|---|---|---|
| Remestemcel-LAn ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis | Drug | Remestemcel-L (150 million cells) |
| Remestemcel-LAn ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis | Drug | Remestemcel-L (300 million cells) |
| PlaceboNormal saline | Other | Placebo |
Primary outcome
Treatment related adverse events
Time frame: Month 3
Number of participants with treatment related adverse events post-injection of 150 or 300 million allogeneic bone marrow derived mesenchymal stem cells for the treatment of medically refractory Ulcerative colitis as assessed by protocol CCF-Stem Cells IBD-005.
5 secondary outcomes
Clinical and endoscopic remission
Time frame: Month 3, Month 12
Clinical and endoscopic response
Time frame: Month 3, Month 12
Partial clinical and endoscopic response
Time frame: Month 3, Month 12
Lack of response
Time frame: Month 3, Month 12
Mayo clinic score
Time frame: Month 1 through Month 24
Results and safety
The study was stopped early (reason given: PI left Cleveland Clinic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 23964933Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739.
- Background: PubMed 28484890Kin C, Kate Bundorf M. As Infliximab Use for Ulcerative Colitis Has Increased, so Has the Rate of Surgical Resection. J Gastrointest Surg. 2017 Jul;21(7):1159-1165. doi: 10.1007/s11605-017-3431-0. Epub 2017 May 8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Amy Lightner principal investigator
Cleveland Clinic Foundation, Cleveland OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Remestemcel-L in people with Ulcerative Colitis, run by The Cleveland Clinic at 1 site in United States.
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 24 inclusion and 47 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: stopped early, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: PI left Cleveland Clinic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related adverse events (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04543994, which also lists 2 linked publications.
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 16 Apr 2026.