A preliminary safety and efficacy evaluation of direct delivery of autologous bone marrow-derived cells in Egyptian patients with type 1 diabetes mellitus
Not Applicable
Completed
- Conditions
- Type 1 diabetes mellitusDigestive System
- Registration Number
- ISRCTN15591075
- Lead Sponsor
- Wadi EL-Neel hospital (JCI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
1. Males and females aged between 2 to 30 years of age
2. Confirmed T1D based on the American Diabetes association (ADA) 2015 criteria for diagnosis
3. Body mass index (BMI) of = 29.9
Exclusion Criteria
1. Active infections
2. Any chronic or acute illness
3. Antibodies to hepatitis B surface antigen
4. Hepatitis C
5. Human immunodeficiency virus or evidence of diabetic complications at baseline
6. Pregnant, are breast-feeding or intend to become pregnant during the study
7. Clinically relevant uncontrolled medical conditions not associated with diabetes (such as hematologic, renal, hepatic, neurologic, cardiac and respiratory conditions)
8. Evidence of active malignancy or a prior history of active malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety is measured using the morbidity, mortality, and unwanted side effects (through patient records) during the procedure and at 12 month follow up.<br>
- Secondary Outcome Measures
Name Time Method 1. Serological changes in positive islet cell and insulin antibody levels are measured using blood samples at baseline and six months<br>2. ß-cell function is measured using blood samples( HbA1c and in FCP and 2h-CP levels) at baseline, month one-two, month three-five, month six-eight and months eight to 12 <br>3. Abdominal pain and other clinical parameters are measured using clinical examination during the procedure and at month one-two, month three-five, month six-eight and month 12