NCT02940418

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sophia Al-Adwan · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus Type 1

Interventions

Type	Name	Description
BIOLOGICAL	Adipose mesenchymal cells with bone marrow mononuclear cells	Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.

Timeline

• Start date: 2017-02-19
• Primary completion: 2019-11-01
• Completion: 2020-01-01
• First posted: 2016-10-20
• Last updated: 2019-07-24

Locations

1 site across 1 country: Jordan