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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
Sophia Al-Adwan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
October 19, 2016
Last Updated
July 23, 2019
Sponsor
Sophia Al-Adwan
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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

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Use of Stem Cells in Diabetes Mellitus Type 1

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