Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease
Ulcerative Colitis Stem Cell Therapy
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2017
CompletedFirst Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedApril 10, 2019
April 1, 2019
2.4 years
September 27, 2017
April 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (1)
Evaluation of the efficacy of the injected cells (Change from Baseline in partial mayo score)
3 months
Study Arms (1)
Wharton Jelly Mesenchymal stem cells
EXPERIMENTALWharton 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
Interventions
Wharton Jelly Mesenchymal stem cells will be injected intravenously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hanan Jafarlead
- Scientific Research Support fundcollaborator
Study Sites (1)
Cell Therapy Center
Amman, 11942, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- DDS. MSc. PhD
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 3, 2017
Study Start
June 5, 2017
Primary Completion
November 1, 2019
Study Completion
January 1, 2020
Last Updated
April 10, 2019
Record last verified: 2019-04