Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus
Efficacy and Safety of Transplantation of Autologous Stem Cells Into Pancreatic Artery, Combined With Immunomodulation for the Treatment of Type 1 Diabetes Mellitus
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2014
Longer than P75 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
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJune 6, 2018
June 1, 2018
3.5 years
December 21, 2015
June 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exogenous insulin dose
1 month
Secondary Outcomes (3)
Anti-GAD titres
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
C-peptide level
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
HbA1c level
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Study Arms (1)
Stem Cell Transplantation
EXPERIMENTALInterventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.
Interventions
Interventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.
Eligibility Criteria
You may qualify if:
- Confirmed Type 1 diabetes mellitus diagnosed for at least 12 months prior to execution of this protocol.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stem Cells Arabia
Amman, 11953, Jordan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2015
First Posted
January 1, 2016
Study Start
February 1, 2014
Primary Completion
August 1, 2017
Study Completion
May 1, 2018
Last Updated
June 6, 2018
Record last verified: 2018-06