Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease

April 9, 2019 updated by: Hanan Jafar, hanan Jafar

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Cell Therapy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Wharton Jelly Mesenchymal stem cells
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
Biological: Wharton Jelly Mesenchymal stem cells
Wharton Jelly Mesenchymal stem cells will be injected intravenously

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of the injected cells (Change from Baseline in partial mayo score)
Time Frame: 3 months
Remission will be considered if reaches 0 points and response if the score diminishes. Endoscopy will be performed at 0 and 12 weeks.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
hanan Jafar

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Scientific Research Support fund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IBDUJCTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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