Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus Type 1, Autoimmune Diseases, Endocrine System Diseases
Status
Completed
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
Stem Cell Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring Stem Cells, Transplantation, Immunomodulation, CD34, CD133, ClinicMACS
Eligibility Criteria
Inclusion Criteria:
- Confirmed Type 1 diabetes mellitus diagnosed for at least 12 months prior to execution of this protocol.
Exclusion Criteria:
- Pregnancy
- Severe psychiatric disorder
- Severe organic impairment (renal, hepatic, cardiac, pulmonary)
- Active infectious disease
- Previous or present neoplastic disease
- Any serious complications due to poor control of diabetes, including: lower limb ischemia, kidney failure, liver failure, vision impairment, peripheral neuropathies, poor circulation.
Sites / Locations
- Stem Cells Arabia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stem Cell Transplantation
Arm Description
Interventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.
Outcomes
Primary Outcome Measures
Exogenous insulin dose
Secondary Outcome Measures
Anti-GAD titres
C-peptide level
HbA1c level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02644759
Brief Title
Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus
Official Title
Efficacy and Safety of Transplantation of Autologous Stem Cells Into Pancreatic Artery, Combined With Immunomodulation for the Treatment of Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stem Cells Arabia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Type 1 diabetes mellitus (T1DM) is a chronic, autoimmune condition that involves the progressive destruction of pancreatic β-cells, eventually resulting in the loss of insulin production and secretion. Hence, an effective treatment for T1DM should focus on controlling anti-β-cell autoimmunity, combined with regeneration of lost pancreatic β-cell populations, with minimal risk to the patient.
This is a phase I and II clinical trial for treatment of patient with confirmed diagnosis of T1DM for at least 12 months prior to enrolment in this trial. This study aims to determine the combined effects of autologous stem cell transplantation and immunomodulation, on regeneration of lost β-cells and halting the immune attack on the pancreatic β-cells, respectively.
Detailed Description
Patients with T1DM depend on administration of exogenous insulin for survival and for control of long-term complications. The best-established treatment is constricted control of blood glucose accomplished by regular daily injections or constant subcutaneous infusion of insulin as intensive insulin therapy. Although insulin therapy has advanced immensely, even the most modern technologies do not allow the maintenance of normal glucose levels.
This is a prospective pilot study intended to treat patients with T1DM after at least one year of confirmed diagnosis. This study encompasses a two-arm approach; the first arm is composed of clinical-grade purification of autologous, leukapheresis-derived, Cluster of differentiation 34+ and 133+ stem cells (accomplished by utilisation of CliniMACS System and approved clinical-grade Microbeads and accessories), and transplantation of the purified ell populations into pancreatic artery and capillaries via interventional radiology techniques; while the second arm aims at halting the immune attack on pancreatic β-cells through immunomodulation, and is composed of incubation of patient's leukapheresis with cord blood-derived mesenchymal stem cells for 3-6 hours, and return of the patient's own white blood cells back into the patient via intravenous injection. Patients are first mobilised with 10 ug/Kg Granulocyte-Colony Stimulating Factor (GCSF) for five day, and then Mononuclear Cells are collected from the patient via leukapheresis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1, Autoimmune Diseases, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases, Metabolic Diseases
Keywords
Stem Cells, Transplantation, Immunomodulation, CD34, CD133, ClinicMACS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem Cell Transplantation
Arm Type
Experimental
Arm Description
Interventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.
Intervention Type
Biological
Intervention Name(s)
Stem Cell Transplantation
Intervention Description
Interventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.
Primary Outcome Measure Information:
Title
Exogenous insulin dose
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Anti-GAD titres
Time Frame
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Title
C-peptide level
Time Frame
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Title
HbA1c level
Time Frame
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed Type 1 diabetes mellitus diagnosed for at least 12 months prior to execution of this protocol.
Exclusion Criteria:
Pregnancy
Severe psychiatric disorder
Severe organic impairment (renal, hepatic, cardiac, pulmonary)
Active infectious disease
Previous or present neoplastic disease
Any serious complications due to poor control of diabetes, including: lower limb ischemia, kidney failure, liver failure, vision impairment, peripheral neuropathies, poor circulation.
Facility Information:
Facility Name
Stem Cells Arabia
City
Amman
ZIP/Postal Code
11953
Country
Jordan
12. IPD Sharing Statement
Learn more about this trial
Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus
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