Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305286
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-16
Brief Title:
Safety Tolerability and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus T1D
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Pilot Study Assessing the Safety of Using a Monoclonal Antibody Against Cluster of Differentiation 40 CD40 Ligand to Achieve a Calcineurin Inhibitor-free Immunosuppression Regimen in Patients With Type 1 Diabetes Mellitus T1D and Problematic Hypoglycemia Undergoing Islet Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AT-1501 is a monoclonal antibody Antibodies are Y-shaped proteins that are produced naturally by the subjects immune system to attack and fight foreign substances that cause illness Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases Monoclonal antibodies can restore enhance or mimic copy the immune systems attack process they can also tone down the immune system AT-1501 is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells For other types of transplants like kidney a drug called a calcineurin inhibitor is usually used to prevent rejection That class of drugs can be toxic to islet cells AT-1501 is an experimental agent that is anticipated to prevent rejection without harming the islet cells
Detailed Description:
By doing this study the study team is studying an investigational regimen containing 2 experimental components
An investigational drug called AT-1501 and
Human pancreatic islet cells
Both AT-1501 and human pancreatic islet cells are considered investigational because they are not currently approved for use in the United States
Islet cells are the specialized cells in the pancreas that produce insulin In this study islet cells will be collected from the pancreas of a deceased organ donor and transplanted into the body The goal of this study is to see whether these transplanted islet cells can take over insulin production The study team will evaluate how well the subject makes insulin and how well-controlled blood sugar is after the transplant
The islet transplant procedure involves inserting a thin flexible tube called a catheter through a small cut in the upper abdomen A radiologist uses X-rays and ultrasound to guide the catheter into the portal vein of the liver where the islet cells are delivered This study of islet transplantation will test to see if islet transplantation is safe and effective
Because these islet cells come from another person the subjects immune system may recognize them as foreign and attack them Standard immunosuppressive medicines Anti-thymocyte globulin ATG or Basiliximab mycophenolate mofetilmycophenolate sodium MMFMPS CellCept and Etanercept will be used to help prevent the body from attacking the transplanted islet cells AT-1501 will be given in combination with these standard immunosuppressive medicines to test whether the investigational drug is safe tolerable and efficacious The effect of the combination of AT-1501 with other immunosuppressant medications has not been previously tested
An investigational drug called AT-1501 and
Human pancreatic islet cells
Both AT-1501 and human pancreatic islet cells are considered investigational because they are not currently approved for use in the United States
Islet cells are the specialized cells in the pancreas that produce insulin In this study islet cells will be collected from the pancreas of a deceased organ donor and transplanted into the body The goal of this study is to see whether these transplanted islet cells can take over insulin production The study team will evaluate how well the subject makes insulin and how well-controlled blood sugar is after the transplant
The islet transplant procedure involves inserting a thin flexible tube called a catheter through a small cut in the upper abdomen A radiologist uses X-rays and ultrasound to guide the catheter into the portal vein of the liver where the islet cells are delivered This study of islet transplantation will test to see if islet transplantation is safe and effective
Because these islet cells come from another person the subjects immune system may recognize them as foreign and attack them Standard immunosuppressive medicines Anti-thymocyte globulin ATG or Basiliximab mycophenolate mofetilmycophenolate sodium MMFMPS CellCept and Etanercept will be used to help prevent the body from attacking the transplanted islet cells AT-1501 will be given in combination with these standard immunosuppressive medicines to test whether the investigational drug is safe tolerable and efficacious The effect of the combination of AT-1501 with other immunosuppressant medications has not been previously tested
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None