Use of Stem Cells in Diabetes Mellitus Type 1

July 23, 2019 updated by: Sophia Al-Adwan

The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial

Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Adipose derived mesenchymal stem cells (ASCs) are to be collected from blood group O donor, cells will be passaged to passage 5.

Before release the sample will be subject to our release criteria which include: testing for any bacterial or fungal growth as well as endotoxin and mycoplasma. All these tests must be negative. In addition the cell count and viability (must be more than 80%) are done before release. Surface markers documentation is done on the cells before release using flow cytometry.

The cells should be infused within 2 hours of release. The dose to is to be repeated after 6 months of a total of two doses in patients. Tests and follow up are to be one at week 12, 24 and 36 when the study is stopped.

These cells will be injected intravenously into patients newly diagnosed with type 1 Diabetes Mellitus.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • 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 Contact

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Recruiting
        • 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

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult Patients with Type 1 Diabetes Mellitus.
  2. Age from 18 years to 35 years either gender.
  3. Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
  4. C-Peptide at inclusion base line should not be less than 0.5 ng/ml
  5. No clinical evidence of renal, retinal, vascular or skin complications
  6. Body Mass Index not exceeding 30
  7. Any HbA1c
  8. At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)
  9. Informed Consent by patient

Exclusion Criteria:

  1. Age less than 18 years and more than 35 years
  2. Pregnancy
  3. Married women or women expected to be married within the study period
  4. History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
  5. Diabetic coma or pre-coma current or recent within the last 2 months
  6. C-Peptide less than 0.5 ng/ml
  7. Disease duration more than 3 yrs.
  8. Complication mentioned in 5 above in inclusion
  9. Non-consenting patient or withdrawal of consent.
  10. Bleeding disorders

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dose 1 mil/kg

Adipose mesenchymal cells with bone marrow mononuclear cells.

Two doses with a 6 month interval of allogenic Adipose mesenchymal cells +1 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously.
Biological: Adipose mesenchymal cells with bone marrow mononuclear cells
Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.
Active Comparator: Dose 10 mil/kg

Adipose mesenchymal cells with bone marrow mononuclear cells.

Two doses with a 6 month interval of allogenic Adipose mesenchymal cells +10 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously.
Biological: Adipose mesenchymal cells with bone marrow mononuclear cells
Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of using allogenic ASC assessed by any adverse events
Time Frame: 6 months
Patients will be assessed for any adverse events as a result of the injection.
6 months

Collaborators and Investigators

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

Sponsor

Sophia Al-Adwan

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)

February 19, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1DM.UJCTC

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

product manufactured in and exported from the U.S.

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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