Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Use of Stem Cells in Diabetes Mellitus Type 1

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by University of Jordan
Sponsor:
Information provided by (Responsible Party):
Sophia Al-Adwan, University of Jordan
ClinicalTrials.gov Identifier:
NCT02940418
First received: October 19, 2016
Last updated: May 3, 2017
Last verified: May 2017
  Purpose
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Jordan:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Actual Study Start Date: February 19, 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Sophia Al-Adwan, Biologist, PhD, University of Jordan
ClinicalTrials.gov Identifier: NCT02940418     History of Changes
Other Study ID Numbers: T1DM.UJCTC
Study First Received: October 19, 2016
Last Updated: May 3, 2017
Individual Participant Data  
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 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

ClinicalTrials.gov processed this record on May 23, 2017