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Use of Stem Cells in Diabetes Mellitus Type 1

Phase 1UnknownNCT02940418
Sophia Al-Adwan20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

20

Conditions

Diabetes Mellitus Type 1

Interventions

Adipose mesenchymal cells with bone marrow mononuclear cellsBIOLOGICAL

Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 Years
Medical Language ↔ Plain English
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

Locations (1)

Cell Therapy Center

Amman, Jordan

RECRUITING

Outcomes

Primary Outcomes

Safety of using allogenic ASC assessed by any adverse events

Patients will be assessed for any adverse events as a result of the injection.

Time frame: 6 months

Central Contacts

Hanan D. Jafar, PhD

CONTACT

00962798871087hanan.jafar@gmail.com
Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.