Use of Stem Cells in Diabetes Mellitus Type 1

Diabetes Mellitus Type 1 Clinical Trial

Official title:

The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940418
• Other study ID #: T1DM.UJCTC
• Status: Recruiting
• Phase: Phase 1
• Start date: February 19, 2017
• Est. completion date: January 2020

Study information

• Verified date: July 2019
• Source: University of Jordan
• Contact: Hanan D. Jafar, PhD
• Phone: 00962798871087
• Email: hanan.jafar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Biological:
• Adipose mesenchymal cells with bone marrow mononuclear cells
Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.

Locations

Country	Name	City	State
Jordan	Cell Therapy Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Sophia Al-Adwan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of using allogenic ASC assessed by any adverse events	Patients will be assessed for any adverse events as a result of the injection.	6 months