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Use of Stem Cells in Diabetes Mellitus Type 1

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ClinicalTrials.gov Identifier: NCT02940418
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sophia Al-Adwan, University of Jordan

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Biological: Adipose mesenchymal cells with bone marrow mononuclear cells Phase 1

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial
Actual Study Start Date : February 19, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940418


Contacts
Contact: Hanan D. Jafar, PhD 00962798871087 hanan.jafar@gmail.com

Locations
Jordan
Cell Therapy Center Recruiting
Amman, Jordan, 11942
Contact: Abdalla Awidi, MD    0096265355000 ext 23960    abdalla.awidi@gmail.com   
Sponsors and Collaborators
Sophia Al-Adwan
Investigators
Study Director: Abdallah Awidi, MD Cell Therapy Center

Responsible Party: Sophia Al-Adwan, Biologist, PhD, University of Jordan
ClinicalTrials.gov Identifier: NCT02940418     History of Changes
Other Study ID Numbers: T1DM.UJCTC
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Sophia Al-Adwan, University of Jordan:
Diabetes Mellitus
Type 1
Adipose derived mesenchymal stem cells

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases