Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Diseases
Status
Unknown status
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
Wharton Jelly Mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Inflammatory Bowel Disease, Mesenchymal stem cells, Ulcerative colitis, Neutrophils
Eligibility Criteria
Inclusion Criteria:
- Single/unmarried females or married females using two modalities of contraception for six months after completion of the study.
- Signed informed consent.
- Patients with previous diagnosis of ulcerative colitis (UC) or newly diagnosed UC based on endoscopic or histopathologic features
- Colitis of any activity
Exclusion Criteria:
- Mental disability that impedes adequate understanding of the study and of the associated procedures.
- Extensive severe toxic colitis requiring admission and IV steroids or biological treatment/surgery.
- Patients with previous colectomies.
- History of malignant disease.
- Pregnant or breastfeeding women.
- Presence of severe concomitant diseases such as chronic obstructive pulmonary disease, Diabetes Mellitus, Cardiovascular and other autoimmune diseases.
- Positive to one or more of the infectious disease panel
Sites / Locations
- Cell Therapy Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wharton Jelly Mesenchymal stem cells
Arm Description
Wharton Jelly Mesenchymal stem cells will be given as a cell suspension in aseptic buffered solution in disposable vials with no preservative agents. The cells will be injected every two weeks at a total of three doses, 120 million cells in 10mls divided on two IV boli for each dose
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death
Secondary Outcome Measures
Evaluation of the efficacy of the injected cells (Change from Baseline in partial mayo score)
Remission will be considered if reaches 0 points and response if the score diminishes. Endoscopy will be performed at 0 and 12 weeks.
Full Information
NCT ID
NCT03299413
First Posted
September 27, 2017
Last Updated
April 9, 2019
Sponsor
Hanan Jafar
Collaborators
Scientific Research Support fund
1. Study Identification
Unique Protocol Identification Number
NCT03299413
Brief Title
Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease
Official Title
Ulcerative Colitis Stem Cell Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hanan Jafar
Collaborators
Scientific Research Support fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Scientists hypothesize that directly or parentally injecting Mesenchymal stem cells (MSCs) to affected areas will have a positive impact through reducing or abolishing intestinal inflammation in part via inhibition of neutrophil Myeloperoxidase (MPOx) activity. Inhibiting MPOx should modify disease progression as well as reduce colitis associated cancer risk.
Detailed Description
Chronic inappropriate mucosal immune activation, due to aberrant host interactions with intestinal microbiota, is at the heart of inflammatory bowel disease (IBD) pathogenesis. Currently, there is no cure for IBD and mainstays of therapy are limited to non-cell specific immunosuppression/immunomodulation, antibiotics and surgery. Advanced ulcerative colitis patients cost approximately 10,000JD in therapy per year with 12.4% of patients presenting with rectal bleeding in Jordan being diagnosed with ulcerative colitis. The role of MSCs in immune modulation is well established in many diseases. However, the therapeutic potential of MSCs directly injected into the inflamed large intestine or parentally has not been fully investigated. Injected MSCs may modulate the IBD immune response particularly lymphoid T-cell and neutrophil activities. While a variety of immune cells contribute to the disease, increased neutrophil activity is associated with greater frequency and severity of active inflammation, as well as increased colitis associated cancer risk. MPOx can transform lipids and polyamines into reactive carbonyl species (RCS) capable of modifying proteins and DNA, altering cell signalling pathways. Finally, MPOx is reported as a useful tool in screening and risk stratification of human ulcerative colitis and colorectal cancer. Inhibiting MPOx in an accelerated preclinical mouse model did reduce incidence and tumor load resulting from gut inflammation. Additionally, in similar preclinical models others have reported that MSC transplantation reduces colitis severity and inflammatory markers including MPOx activity. Even in the absence of the well-known MSC T-cell immune modulation, disease activity indices and MPOx activity were reduced in these models. In addition to following traditional clinical outcomes, Reseachers will analyze gut immune responses, specifically neutrophil MPOx activity along with other IBD immune markers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Inflammatory Bowel Disease, Mesenchymal stem cells, Ulcerative colitis, Neutrophils
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wharton Jelly Mesenchymal stem cells
Arm Type
Experimental
Arm Description
Wharton Jelly Mesenchymal stem cells will be given as a cell suspension in aseptic buffered solution in disposable vials with no preservative agents. The cells will be injected every two weeks at a total of three doses, 120 million cells in 10mls divided on two IV boli for each dose
Intervention Type
Biological
Intervention Name(s)
Wharton Jelly Mesenchymal stem cells
Intervention Description
Wharton Jelly Mesenchymal stem cells will be injected intravenously
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluation of the efficacy of the injected cells (Change from Baseline in partial mayo score)
Description
Remission will be considered if reaches 0 points and response if the score diminishes. Endoscopy will be performed at 0 and 12 weeks.
Time Frame
3 months
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:
Single/unmarried females or married females using two modalities of contraception for six months after completion of the study.
Signed informed consent.
Patients with previous diagnosis of ulcerative colitis (UC) or newly diagnosed UC based on endoscopic or histopathologic features
Colitis of any activity
Exclusion Criteria:
Mental disability that impedes adequate understanding of the study and of the associated procedures.
Extensive severe toxic colitis requiring admission and IV steroids or biological treatment/surgery.
Patients with previous colectomies.
History of malignant disease.
Pregnant or breastfeeding women.
Presence of severe concomitant diseases such as chronic obstructive pulmonary disease, Diabetes Mellitus, Cardiovascular and other autoimmune diseases.
Positive to one or more of the infectious disease panel
Facility Information:
Facility Name
Cell Therapy Center
City
Amman
ZIP/Postal Code
11942
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease
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