Use of Stem Cells in Diabetes Mellitus Type 1

Phase 1

• Conditions: Diabetes Mellitus Type 1
• Interventions: Biological: Adipose mesenchymal cells with bone marrow mononuclear cells

• Registration Number: NCT02940418
• Lead Sponsor: Sophia Al-Adwan

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.

Study Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Study Start: 2017-02-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24
• Primary Completion: 2019-11
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 10 mil/kg	Adipose mesenchymal cells with bone marrow mononuclear cells	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.
Dose 1 mil/kg	Adipose mesenchymal cells with bone marrow mononuclear cells	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cell Therapy Center; 🇯🇴 Amman, Jordan