Diabetes Mellitus Type 1
Conditions
Keywords
Diabetes Mellitus, Type 1, Adipose derived mesenchymal stem cells
Brief summary
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus
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.
Interventions
BIOLOGICALAdipose mesenchymal cells with bone marrow mononuclear cells
Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.
Sponsors
Sophia Al-Adwan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of using allogenic ASC assessed by any adverse events | 6 months | Patients will be assessed for any adverse events as a result of the injection. |
Countries
Jordan
Contacts
Primary ContactHanan D. Jafar, PhD
Outcome results
None listed