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Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02644759
Recruitment Status : Recruiting
First Posted : January 1, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Stem Cells Arabia

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Autoimmune Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Biological: Stem Cell Transplantation Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stem Cell Transplantation
Interventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.
Biological: Stem Cell Transplantation
Interventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.



Primary Outcome Measures :
  1. Exogenous insulin dose [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Anti-GAD titres [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months ]
  2. C-peptide level [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months ]
  3. HbA1c level [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months ]


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Ages Eligible for Study:   8 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644759


Contacts
Contact: Adeeb AlZoubi, PhD 00962795337575 adeebalzoubi@stemcellsarabia.net

Locations
Jordan
Stem Cells Arabia Recruiting
Amman, Jordan, 11953
Contact: Adeeb AlZoubi, PhD    00962795337575    adeebalzoubi@stemcellsarabia.net   
Sponsors and Collaborators
Stem Cells Arabia

Responsible Party: Stem Cells Arabia
ClinicalTrials.gov Identifier: NCT02644759     History of Changes
Other Study ID Numbers: SCA-DM1
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: December 2016

Keywords provided by Stem Cells Arabia:
Stem Cells
Transplantation
Immunomodulation
CD34
CD133
ClinicMACS

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Metabolic Diseases
Glucose Metabolism Disorders
Immune System Diseases
Endocrine System Diseases