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
1 other identifier
interventional
20
1 country
1
Brief Summary
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2016
CompletedFirst Posted
Study publicly available on registry
October 20, 2016
CompletedStudy Start
First participant enrolled
February 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJuly 24, 2019
July 1, 2019
2.7 years
October 19, 2016
July 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of using allogenic ASC assessed by any adverse events
Patients will be assessed for any adverse events as a result of the injection.
6 months
Study Arms (2)
Dose 1 mil/kg
ACTIVE COMPARATORAdipose 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.
Dose 10 mil/kg
ACTIVE COMPARATORAdipose 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.
Interventions
Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
- Non-consenting patient or withdrawal of consent.
- Bleeding disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sophia Al-Adwanlead
Study Sites (1)
Cell Therapy Center
Amman, 11942, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Abdallah Awidi, MD
Cell Therapy Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Biologist, PhD
Study Record Dates
First Submitted
October 19, 2016
First Posted
October 20, 2016
Study Start
February 19, 2017
Primary Completion
November 1, 2019
Study Completion
January 1, 2020
Last Updated
July 24, 2019
Record last verified: 2019-07