Inflammatory Bowel DiseasesPhase 1/2NCT03299413
Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease
A Phase 1/2 study testing Wharton Jelly Mesenchymal stem cells in people with Inflammatory Bowel Diseases, run by Hanan Jafar at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Wharton Jelly Mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- 5 Jun 2017to Jan 2020
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ulcerative Colitis Stem Cell Therapy
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Wharton Jelly Mesenchymal stem cells
- Keywords
- Inflammatory Bowel Disease, Mesenchymal stem cells, Ulcerative colitis, Neutrophils
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wharton Jelly Mesenchymal stem cellsBiological
Wharton Jelly Mesenchymal stem cells will be injected intravenously
| Study group | Role | What they receive |
|---|---|---|
| Wharton Jelly Mesenchymal stem cells | Experimental | 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 Receives: Biological: Wharton Jelly Mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start5 Jun 2017
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanan Jafar
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Support fund
- Responsible party
- Sponsor-investigator, Hanan Jafar, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299413
- Sponsor's protocol ID
- IBDUJCTC
- Status last verified
- Apr 2019
- First submitted
- 27 Sep 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulcerative Colitis Stem Cell Therapy
- ClinicalTrials.gov ID
- NCT03299413
- Acronym / sponsor ID
- IBDUJCTC
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Disease, Mesenchymal stem cells, Ulcerative colitis, Neutrophils
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hanan JafarUniversity, hospital or other
- Collaborators
- Scientific Research Support fund
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 3 Oct 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wharton Jelly Mesenchymal stem cells | Experimental | Biological: Wharton Jelly Mesenchymal stem cellsWharton 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Wharton Jelly Mesenchymal stem cellsWharton Jelly Mesenchymal stem cells will be injected intravenously | Biological | Wharton Jelly Mesenchymal stem cells |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 6 months
Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death
1 secondary outcome
Evaluation of the efficacy of the injected cells (Change from Baseline in partial mayo score)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Wharton Jelly Mesenchymal stem cells in people with Inflammatory Bowel Diseases, run by Hanan Jafar at 1 site in Jordan.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Apr 2019. 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 Jordan. 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. 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?
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 6 months). 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 10 Apr 2019.