Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02644759
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2015-12-21
Brief Title:
Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus
Sponsor:
Stem Cells Arabia
Organization:
Stem Cells Arabia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients leukapheresis with cord blood-derived mesenchymal stem cells for 3-6 hours and return of the patients own white blood cells back into the patient via intravenous injection Patients are first mobilised with 10 ugKg Granulocyte-Colony Stimulating Factor GCSF for five day and then Mononuclear Cells are collected from the patient via leukapheresis
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 patients leukapheresis with cord blood-derived mesenchymal stem cells for 3-6 hours and return of the patients own white blood cells back into the patient via intravenous injection Patients are first mobilised with 10 ugKg Granulocyte-Colony Stimulating Factor GCSF for five day and then Mononuclear Cells are collected from the patient via leukapheresis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None