Use of Stem Cells in Diabetes Mellitus Type 1
Primary Purpose
Diabetes Mellitus Type 1
Status
Unknown status
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
Adipose mesenchymal cells with bone marrow mononuclear cells
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring Diabetes Mellitus, Type 1, Adipose derived mesenchymal stem cells
Eligibility Criteria
Inclusion Criteria:
- Adult Patients with Type 1 Diabetes Mellitus.
- Age from 18 years to 35 years either gender.
- Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
- C-Peptide at inclusion base line should not be less than 0.5 ng/ml
- No clinical evidence of renal, retinal, vascular or skin complications
- Body Mass Index not exceeding 30
- Any HbA1c
- At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)
- Informed Consent by patient
Exclusion Criteria:
- Age less than 18 years and more than 35 years
- Pregnancy
- Married women or women expected to be married within the study period
- History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
- Diabetic coma or pre-coma current or recent within the last 2 months
- C-Peptide less than 0.5 ng/ml
- Disease duration more than 3 yrs.
- Complication mentioned in 5 above in inclusion
- Non-consenting patient or withdrawal of consent.
- Bleeding disorders
Sites / Locations
- Cell Therapy CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dose 1 mil/kg
Dose 10 mil/kg
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Safety of using allogenic ASC assessed by any adverse events
Patients will be assessed for any adverse events as a result of the injection.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02940418
Brief Title
Use of Stem Cells in Diabetes Mellitus Type 1
Official Title
The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2017 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sophia Al-Adwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1
Keywords
Diabetes Mellitus, Type 1, Adipose derived mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose 1 mil/kg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dose 10 mil/kg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Adipose mesenchymal cells with bone marrow mononuclear cells
Intervention Description
Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.
Primary Outcome Measure Information:
Title
Safety of using allogenic ASC assessed by any adverse events
Description
Patients will be assessed for any adverse events as a result of the injection.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Patients with Type 1 Diabetes Mellitus.
Age from 18 years to 35 years either gender.
Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
C-Peptide at inclusion base line should not be less than 0.5 ng/ml
No clinical evidence of renal, retinal, vascular or skin complications
Body Mass Index not exceeding 30
Any HbA1c
At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)
Informed Consent by patient
Exclusion Criteria:
Age less than 18 years and more than 35 years
Pregnancy
Married women or women expected to be married within the study period
History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
Diabetic coma or pre-coma current or recent within the last 2 months
C-Peptide less than 0.5 ng/ml
Disease duration more than 3 yrs.
Complication mentioned in 5 above in inclusion
Non-consenting patient or withdrawal of consent.
Bleeding disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan D. Jafar, PhD
Phone
00962798871087
Email
hanan.jafar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdallah Awidi, MD
Organizational Affiliation
Cell Therapy Center
Official's Role
Study Director
Facility Information:
Facility Name
Cell Therapy Center
City
Amman
ZIP/Postal Code
11942
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdalla Awidi, MD
Phone
0096265355000
Ext
23960
Email
abdalla.awidi@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Use of Stem Cells in Diabetes Mellitus Type 1
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