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Use of Stem Cells in Diabetes Mellitus Type 1

This study is currently recruiting participants.
Verified May 2017 by Sophia Al-Adwan, University of Jordan
Sponsor:
ClinicalTrials.gov Identifier:
NCT02940418
First Posted: October 20, 2016
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sophia Al-Adwan, University of Jordan
October 19, 2016
October 20, 2016
May 8, 2017
February 19, 2017
January 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02940418 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Use of Stem Cells in Diabetes Mellitus Type 1
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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus Type 1
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 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.

    Intervention: Biological: Adipose mesenchymal cells with bone marrow mononuclear cells
  • 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.

    Intervention: Biological: Adipose mesenchymal cells with bone marrow mononuclear cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2018
January 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
No
Contact: Hanan D. Jafar, PhD 00962798871087 hanan.jafar@gmail.com
Jordan
 
 
NCT02940418
T1DM.UJCTC
Yes
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
Plan to Share IPD: Undecided
Sophia Al-Adwan, University of Jordan
Sophia Al-Adwan
Not Provided
Study Director: Abdallah Awidi, MD Cell Therapy Center
University of Jordan
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP