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Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC) (UC)

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Remestemcel-L
Remestemcel-L
Placebo
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, medically refractory ulcerative colitis, UC, refractory ulcerative colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Males and Females 18-75 years of age.
  2. Ulcerative colitis of at least 6 months duration with medically refractory symptoms
  3. 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.

    1. 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.
    2. If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks.
    3. If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks.
    4. 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.
    5. If receiving budesonide, the dose must have been stable for at least 2 weeks.
    6. If oral 5-ASA compounds or oral corticosteroids (including budesonide) have been recently discontinued, they must have been stopped for at least 2 weeks.
  4. The following medications/therapies must have been discontinued before first administration of study agent:

    1. TNF-antagonist therapy (eg, infliximab, etanercept, certolizumab, adalimumab, golimumab), vedolizumab, ustekinumab for at least 4 weeks.
    2. Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks.
    3. 6-thioguanine (6-TG) must have been discontinued for at least 4 weeks.
    4. Rectal corticosteroids (ie, corticosteroids [including budesonide] administered to the
    5. rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks.
    6. Rectal 5-ASA compounds (ie, 5-ASAs administered to the rectum or sigmoid colon viafoam or enema or suppository) for at least 2 weeks.
    7. Parenteral corticosteroids for at least 2 weeks.
    8. Total parenteral nutrition (TPN) for at least 2 weeks.
    9. Antibiotics for the treatment of UC (eg, ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks.
  5. No colonic dysplasia and malignancy as ruled out by colonoscopy within 30 days of MSC delivery
  6. Ability to comply with protocol
  7. Competent and able to provide written informed consent
  8. 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
  9. If patient is of reproductive capacity, willing to use adequate birth control measures while they are in the study

Exclusion Criteria for all patients to join the protocol

  1. Inability to give informed consent.
  2. 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.
  3. Specific exclusions;

    1. HIV
    2. Hepatitis B or C
  4. Abnormal AST or ALT at screening defined as AST >100 or ALT > 100
  5. Abnormal basic laboratory values with the following cut-offs:

    1. Alkaline phosphate >200
    2. WBC >13
    3. Hemoglobin <7
    4. Platelets <50 or > 1 million
    5. Creatinine >1.5
  6. History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
  7. Investigational drug within one year of study enrollment
  8. Pregnant or breast feeding.
  9. Fulminant colitis requiring emergency surgery
  10. Concurrent active clostridium difficile infection of the colon
  11. Concurrent CMV infection of the colon
  12. Evidence of colonic perforation
  13. Massive hemorrhage from the colon requiring emergent surgery
  14. Crohn's colitis or indeterminate colitis
  15. Microscopic, ischemic or infectious colitis
  16. Neoplasia of the colon and preoperative biopsy
  17. Presence of an ostomy
  18. Prior small bowel resection
  19. Previous colonic resection
  20. Colonic stricture that unable to pass an adult colonoscope
  21. Active or latent tuberculosis
  22. Unable to wean off corticosteroids
  23. Patients with extra colonic ulcerative colitis including primary sclerosing cholangitis
  24. 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
  25. Patients with known allergy to local anesthetics
  26. Patients with a known allergy to DMSO, porcine and/or bovine proteins
  27. Patients taking anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix) to reduce the risk of bleeding/ hemarthrosis
  28. 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:

  1. Received placebo at the point of first injection
  2. Completed all study visits to date
  3. Clinical status has remained the same or improved, not worsened

Exclusion Criteria for control patients who will be entering the treatment phase:

  1. Required repeat hospitalization for a colitis flare
  2. Given oral and intravenous steroids for a colitis flare
  3. Had worsening abdominal pain frequency of bowel movements, blood in stool
  4. Desires exclusion from the study to pursue escalation in medical management or surgery Allogeneic Bone
  5. Has a colonic perforation that requires surgery
  6. Has colonic bleeding that requires surgery

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Remestemcel-L (150 million cells)

Remestemcel-L (300 million cells)

Placebo

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
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).

Full Information

First Posted
September 3, 2020
Last Updated
April 4, 2022
Sponsor
The Cleveland Clinic
Collaborators
Mesoblast, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04543994
Brief Title
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)
Acronym
UC
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Mesoblast, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, medically refractory ulcerative colitis, UC, refractory ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remestemcel-L (150 million cells)
Arm Type
Experimental
Arm Description
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).
Arm Title
Remestemcel-L (300 million cells)
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Remestemcel-L
Intervention Description
An ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis
Intervention Type
Drug
Intervention Name(s)
Remestemcel-L
Intervention Description
An ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Treatment related adverse events
Description
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.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Clinical and endoscopic remission
Description
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
Time Frame
Month 3, Month 12
Title
Clinical and endoscopic response
Description
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
Time Frame
Month 3, Month 12
Title
Partial clinical and endoscopic response
Description
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
Time Frame
Month 3, Month 12
Title
Lack of response
Description
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
Time Frame
Month 3, Month 12
Title
Mayo clinic score
Description
Mayo clinic score will be used to measure quality of life in participants. *Score ranges from 0 (least severe) to 12(most severe).
Time Frame
Month 1 through Month 24
Other Pre-specified Outcome Measures:
Title
Inflammatory bowel disease questionnaire
Description
Inflammatory bowel disease questionnaire will be used to measure quality of life in participants. *Score ranges from 32 (best health) to 224 (worst health)
Time Frame
Month 1 through Month 24
Title
EuroQol 5 Dimensions survey
Description
EuroQol 5 Dimensions survey will be used to measure quality of life in participants. *Score ranges from 5 (full health) to 25 (worst health).
Time Frame
Month 1 through Month 24
Title
IBD-patient reported treatment impact survey
Description
IBD-patient reported treatment impact survey will be used to measure quality of life in participants. *Score ranges from 3 (most satisfied) to 15 (least satisfied)
Time Frame
Month 1 through Month 24
Title
Short Form 36 health survey
Description
Short Form 36 health survey will be used to measure quality of life in participants. *Score ranges from 0 (least favorable health state) to 3600 (most favorable health state)
Time Frame
Month 1 through Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. 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 Exclusion Criteria for all patients to join the protocol 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Bayles, AA
Phone
216-444-0887
Email
ibdstemcelltherapy@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alex VanDenBossche, BSN
Phone
216-379-0307
Email
ibdstemcelltherapy@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Lightner
Organizational Affiliation
Cleveland Clinic Foundation, Cleveland OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Bayles

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23964933
Citation
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.
Results Reference
background
PubMed Identifier
28484890
Citation
Kin 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.
Results Reference
background

Learn more about this trial

Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)

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