| 1 |
NCT02846571 |
Not yet recruiting |
Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye |
|
- Biological: Human Pancreatic Islet Transplantation
|
Interventional |
Phase 1
Phase 2 |
- Rodolfo Alejandro
- Diabetes Research Institute Foundation
- Bascom Palmer Eye Institute
- University of Miami
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction (≥ 50%) of glycemia fluctuations
- Reduction (≥ 25%) in exogenous insulin requirements
- Increased (≥ 1x) unstimulated serum c-peptide (corrected to glycemia) compared to baseline before transplant
- HbA1C ≤ 7% or a ≥ 2.5 decrease from baseline (before transplant)
|
10 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02846571 |
20160640 |
|
August 2018 |
December 2020 |
December 2021 |
July 27, 2016 |
January 12, 2018 |
|
- Bascom Palmer Eye Institute
Miami, Florida, United States - Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States
|
| 2 |
NCT01897688 |
Recruiting |
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients |
- Type 1 Diabetes
- Severe Hypoglycemic Unawareness
|
- Biological: Islet Cell Transplant
|
Interventional |
Phase 3 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes.
- To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics.
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT01897688 |
STU00059469 |
|
June 2012 |
March 2020 |
March 2021 |
July 12, 2013 |
April 20, 2018 |
|
- Northwestern University
Chicago, Illinois, United States
|
| 3 |
NCT02916680 |
Recruiting |
Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study |
|
- Procedure: Pancreatic islet transplantation in the anterior chamber
|
Interventional |
Not Applicable |
- University Hospital, Basel, Switzerland
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Absence of ophthalmic complications
- Change in insulin production
- Change in insulin requirements
- (and 3 more...)
|
4 |
All |
18 Years and older (Adult, Senior) |
NCT02916680 |
Eye ITPL |
|
March 2016 |
April 2018 |
April 2018 |
September 27, 2016 |
April 17, 2018 |
|
- University Hospital Basel
Basel, Switzerland
|
| 4 |
NCT00679042 |
Recruiting |
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol |
|
- Drug: Islets of Langerhans transplantation
|
Interventional |
Phase 3 |
- University of Illinois at Chicago
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety: Incidence and severity of events related to islet infusion, immunosuppression, and islet preparations
- The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events
- Insulin independence
- (and 2 more...)
|
1000 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00679042 |
IND11807-2007-0330 |
|
June 2007 |
August 2017 |
September 2017 |
May 16, 2008 |
May 30, 2017 |
|
- University of Illinois at Chicago Medical Center
Chicago, Illinois, United States
|
| 5 |
NCT01909245 |
Recruiting |
Islet Cell Transplant for Type 1 Diabetes |
|
- Biological: Allogenic Human Islet Cells
|
Interventional |
Phase 2 |
- City of Hope Medical Center
- University of California, Los Angeles
- Benaroya Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c ≤ 6.5%
- Reduction/Elimination of hypoglycemia
|
30 |
All |
18 Years to 68 Years (Adult, Senior) |
NCT01909245 |
12446 |
TCD |
October 2013 |
July 2021 |
July 2021 |
July 26, 2013 |
December 15, 2017 |
|
- City of Hope Medical Center
Duarte, California, United States
|
| 6 |
NCT02854696 |
Recruiting |
Health Economic Analysis of Islet Cell Transplantation for the Stabilization of the Severe Forms of Type 1 Diabetes |
|
- Procedure: Islet graft
- Drug: best medical care
|
Interventional |
Phase 3 |
- University Hospital, Grenoble
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incremental cost- utility ratio at 1 year
- Cost-effectiveness ratio at 1 year
- Assessment of individual medical benefit of quality of life
- (and 5 more...)
|
40 |
All |
18 Years to 65 Years (Adult) |
NCT02854696 |
38RC14.453 |
STABILOT |
July 2016 |
March 2023 |
December 2023 |
August 3, 2016 |
March 17, 2017 |
|
- University Hospital of Besançon
Besancon, France - university hospital of Clermont Ferrand
Clermont Ferrand, France - Grenoble University Hospital
Grenoble, France - (and 8 more...)
|
| 7 |
NCT02627690 |
Recruiting |
Nephrologic Prognosis 10 Years After Diabetes Cell Therapy |
|
- Other: islet transplanted
- Other: non islet transplanted
|
Observational |
|
- University Hospital, Lille
|
Other |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
- Modification of Diet in Renal Disease (MDRD)
- number of cardiovascular events
- number of deaths
|
50 |
All |
18 Years to 65 Years (Adult) |
NCT02627690 |
2013_28
2014-A00141-46 |
PRONOCELDIAB |
September 2014 |
December 2019 |
December 2019 |
December 11, 2015 |
February 2, 2017 |
|
- Lille University Hospital
Lille, France
|
| 8 |
NCT03444064 |
Recruiting |
PolyTreg Immunotherapy in Islet Transplantation |
- Diabetes
- Diabetes Mellitus, Type 1
|
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events
- Stimulated C-peptide level
|
18 |
All |
18 Years to 68 Years (Adult, Senior) |
NCT03444064 |
Pro00071320 |
|
February 1, 2018 |
March 2020 |
March 2021 |
February 23, 2018 |
February 27, 2018 |
|
- University of Alberta
Edmonton, Alberta, Canada
|
| 9 |
NCT02213003 |
Recruiting |
Allogeneic Islet Cells Transplanted Onto the Omentum |
- Type 1 Diabetes Mellitus
- Hypoglycemia
- Hypoglycemia Unawareness
|
- Biological: Islet transplantation
|
Interventional |
Phase 1
Phase 2 |
- Rodolfo Alejandro
- Juvenile Diabetes Research Foundation
- Diabetes Research Institute Foundation
- University of Miami
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- A1c </= 6.5% and no severe hypoglycemia
- procedural complications
|
6 |
All |
18 Years to 65 Years (Adult) |
NCT02213003 |
20140144 |
|
September 2014 |
May 2019 |
May 2020 |
August 11, 2014 |
October 9, 2017 |
|
- Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States
|
| 10 |
NCT02402439 |
Recruiting |
Treatment of Type I Diabetes by Islet Transplantation Into the Gastric Submucosa Study Protocol |
- Diabetes Mellitus, Type 1
|
- Drug: Islet cells
- Procedure: Islet transplantation into the gastrointestinal submucosa
|
Interventional |
Phase 1 |
- University of California, San Francisco
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Insulin independence
- Changes in HbA1c
- Changes (reduction) in insulin requirements
- Incidence of adverse events
|
6 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02402439 |
IGS |
|
March 2016 |
January 2021 |
January 2021 |
March 30, 2015 |
April 5, 2018 |
|
- University of California, San Francisco
San Francisco, California, United States
|
| 11 |
NCT03063229 |
Recruiting |
Energy Balance Following Islet Transplantation |
|
- Device: Accelerometer
- Other: Anthropomentry
- Procedure: Blood tests
- (and 9 more...)
|
Interventional |
Not Applicable |
- University of Edinburgh
- NHS Lothian
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Body composition
- Total energy intake
- The activity component of energy expenditure using accelerometry.
- (and 7 more...)
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03063229 |
REC 16/SS0031 R&D: 2016/0118 |
EBFIT |
June 2016 |
September 2018 |
September 2019 |
February 24, 2017 |
February 24, 2017 |
|
- Royal Infirmary Edinburgh
Edinburgh, Midlothian, United Kingdom
|
| 12 |
NCT02004964 |
Recruiting |
Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation |
|
|
Observational |
|
- Rodolfo Alejandro
- University of Miami
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- eligibility for islet transplantation
|
600 |
All |
18 Years to 65 Years (Adult) |
NCT02004964 |
20053135 |
|
April 2009 |
April 2019 |
December 2020 |
December 9, 2013 |
October 9, 2017 |
|
- Diabetes Research Institute
Miami, Florida, United States
|
| 13 |
NCT03073577 |
Recruiting |
Islet Transplantation Using PKX-001 |
|
- Drug: Antiaging Glycopeptide
|
Interventional |
Phase 1 |
- University of Alberta
- ProtoKinetix Inc.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse event morbidity
- Serious adverse event morbidity
- Number of participants with insulin independence
- (and 7 more...)
|
10 |
All |
18 Years to 68 Years (Adult, Senior) |
NCT03073577 |
Pro00067564 |
|
February 16, 2017 |
September 2018 |
January 2019 |
March 8, 2017 |
March 8, 2017 |
|
- University of Alberta
Edmonton, Alberta, Canada
|
| 14 |
NCT01630850 |
Recruiting |
Islet Transplantation in Patients With "Brittle" Type I Diabetes |
- Diabetes Mellitus, Type 1
|
- Biological: Allogenic islet cells (human, U. Chicago)
- Procedure: Intraportal infusion of islet cells
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HbAlc <7.0% and an absence of severe hypoglycemic events
|
20 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01630850 |
11-0684 |
|
May 2012 |
May 2018 |
June 2021 |
June 28, 2012 |
June 9, 2017 |
|
- University of Chicago Medical Center
Chicago, Illinois, United States
|
| 15 |
NCT02803905 |
Recruiting |
Islet Transplant Alone in OMENtum |
- Islets of Langerhans Transplantation
- Diabetes Mellitus, Type 1
|
- Biological: Biological: Islet transplantation
|
Interventional |
Phase 2 |
- Piemonti Lorenzo
- Ospedale San Raffaele
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- A1c </= 6.5% and no severe hypoglycemia
- Insulin requirements
- Insulin secretion
- (and 2 more...)
|
12 |
All |
18 Years to 65 Years (Adult) |
NCT02803905 |
ITA OMEN |
ITA-OMEN |
April 2016 |
March 2020 |
December 2020 |
June 17, 2016 |
February 8, 2018 |
|
- IRCCS San Raffaele Scientific Institute
Milan, Italy
|
| 16 |
NCT01974674 |
Recruiting |
Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes |
- Patients With Type 1 Diabetes
|
- Procedure: Allogeneic transplantation of intrahepatic islet
|
Interventional |
Phase 2 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- restoration of normal glycemic control without insulin
- Restoration of normal glycemic control without insulin for a year
- Obtaining an improvement in glycemic control
- (and 10 more...)
|
19 |
All |
18 Years to 55 Years (Adult) |
NCT01974674 |
P030415 |
GRIIF |
July 2013 |
December 2016 |
January 2022 |
November 1, 2013 |
September 29, 2016 |
|
- Saint Louis hospital
Paris, Ile de France, France
|
| 17 |
NCT00678990 |
Not yet recruiting |
Heparinized Islets in Clinical Islet Transplantation |
|
- Procedure: Transplantation of islets with heparin coating
|
Interventional |
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
10 |
All |
18 Years to 65 Years (Adult) |
NCT00678990 |
SAL-01 |
|
January 2018 |
December 2018 |
December 2018 |
May 16, 2008 |
August 22, 2017 |
|
- Department of Transplantation Surgery, Karolinska University Hospital
Stockholm, Sweden - Department of Transplantation and Liver Surgery, Uppsala University Hospital
Uppsala, Sweden
|
| 18 |
NCT02727608 |
Recruiting |
Complement Inhibitor Eculizumab in Clinical Islet Transplantation |
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Increased survival of ICC´s transplanted as measured by peak c-peptide
- Effect of eculizumab on instant blood mediated inflammatory reaction (IBMIR) as determined by complement activation.
- Monitoring of islet-function and survival.
- (and 5 more...)
|
10 |
All |
18 Years to 65 Years (Adult) |
NCT02727608 |
ICC version 2
2014-005421-12 |
ICC |
May 15, 2016 |
May 2018 |
June 2018 |
April 4, 2016 |
May 19, 2017 |
|
- Dept of Surgical Sciences, Section of Transplantation Surgery, University Hospital
Uppsala, Sweden
|
| 19 |
NCT03079921 |
Recruiting |
Adrenergic System in Islet Transplantation |
- Type1diabetes
- Hypoglycemia
|
- Drug: Phentolamine
- Drug: Propranolol
- Drug: Placebo
|
Interventional |
Not Applicable |
- University of Pennsylvania
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- C-PEPTIDE suppression during hyperinsulinemia euglycemia.
- GLUCAGON activation during hyperinsulinemia hypoglycemia.
- EPINEPHRINE during hyperinsulinemia hypoglycemia.
- (and 2 more...)
|
45 |
All |
21 Years to 65 Years (Adult) |
NCT03079921 |
826386
2R01DK091331-06 |
|
January 20, 2017 |
December 2019 |
December 2020 |
March 15, 2017 |
March 20, 2017 |
|
- University of Pennsylvania - Institute for Diabetes, Obesity and Metabolism
Philadelphia, Pennsylvania, United States
|
| 20 |
NCT03283566 |
Recruiting |
Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT |
- Chronic Pancreatitis
- Insulin Dependent Diabetes
|
- Drug: Hydroxychloroquine
- Drug: Placebo
|
Interventional |
Phase 2 |
- The Cleveland Clinic
- Allegheny Singer Research Institute
- Stanford University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Quotient of stimulated C-peptide/glucose level normalized for IEQ/Kg infused in response to MMTT
- C-peptide AUC in response to MMTT
- Ratio of C-peptide AUC to glucose AUC in response to MMTT
|
10 |
All |
18 Years to 65 Years (Adult) |
NCT03283566 |
17-912 |
|
October 3, 2017 |
October 3, 2019 |
October 3, 2019 |
September 14, 2017 |
November 8, 2017 |
|
- Cleveland Clinic
Cleveland, Ohio, United States
|
| 21 |
NCT01702051 |
Recruiting |
Extending Indication for Islet Autotransplantation in Pancreatic Surgery |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Beta cell function
- Incidence of complications after pancreatic surgery
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT01702051 |
43-09/02/2012 |
AutoTx |
February 2012 |
October 2018 |
October 2018 |
October 5, 2012 |
February 8, 2018 |
|
- Ospedale San Raffaele (OSR)
Milan, Italy
|
| 22 |
NCT02505893 |
Recruiting |
Minimal Islet Transplant at Diabetes Onset |
- Diabetes Mellitus, Type 1
|
- Biological: Human pancreatic islet
- Drug: ATG
- Drug: Pegylated G-CSF
- Drug: Rapamycin
|
Interventional |
Phase 2 |
- Ospedale San Raffaele
- Fondazione Italiana Diabete Onlus
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- plasma C-peptide AUC (mixed meal tolerance test [MMTT])
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
- plasma C-peptide AUC (MMTT)
- (and 6 more...)
|
6 |
All |
18 Years to 45 Years (Adult) |
NCT02505893 |
DRI-MITO 1/2014 |
MITO |
April 2015 |
May 2018 |
May 2018 |
July 22, 2015 |
February 8, 2018 |
|
- IRCCS San Raffaele Scientific Institute
Milan, Italy
|
| 23 |
NCT02567240 |
Recruiting |
Carbon Monoxide-Saturated Medium for Islet Isolation |
|
- Other: Carbon monoxide-bubbled mediums
|
Interventional |
Phase 1 |
- Medical University of South Carolina
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Area under the curve during mixed meal tolerance test
|
24 |
All |
18 Years to 69 Years (Adult, Senior) |
NCT02567240 |
Pro00040035 |
|
January 2015 |
December 2018 |
December 2018 |
October 2, 2015 |
April 2, 2018 |
|
- GI Surgery, Medical University of South Carolina
Charleston, South Carolina, United States
|
| 24 |
NCT03427931 |
Recruiting |
CGM Use in Islet Transplant Recipients |
- Islet Transplantation
- Type1 Diabetes Mellitus
|
- Other: Continuous Glucose Monitor (CGM)
|
Interventional |
Not Applicable |
- University of Virginia
- University of Virginia Strategic Investment Fund
- DexCom, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Percentage time in range 70-180 mg/dL by CGM
- Percentage time in range <70 mg/dL by CGM
|
6 |
All |
18 Years and older (Adult, Senior) |
NCT03427931 |
20294 |
|
February 1, 2018 |
June 30, 2018 |
December 31, 2018 |
February 9, 2018 |
February 9, 2018 |
|
- University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
|
| 25 |
NCT02821026 |
Recruiting |
Omental Islet Transplant |
|
- Procedure: Omental Islet transplant
- Drug: Anti-Thymocyte Globulin
- Drug: Mycophenolate mofetil
- (and 3 more...)
|
Interventional |
Phase 1
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The incidence of Serious Adverse Events
- The proportion of subjects with HbA1c ≤ 6.5% at 1 year AND free of severe hypoglycemic events from Day 28 to Day 365, inclusive, after the islet transplant
- The percent reduction in insulin requirements at Day 75±7 after islet transplant
- (and 59 more...)
|
6 |
All |
18 Years to 65 Years (Adult) |
NCT02821026 |
Pro00058260 |
|
September 2015 |
September 2018 |
September 2018 |
July 1, 2016 |
July 1, 2016 |
|
- Clinical Islet Transplant Program
Edmonton, Alberta, Canada
|
| 26 |
NCT03067324 |
Recruiting |
Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol |
- Pancreatic Islet Quality Control
|
|
Observational |
|
- University Hospital, Grenoble
- University Hospital, Bordeaux
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
40 |
All |
18 Years to 65 Years (Adult) |
NCT03067324 |
38RC14.041 |
ISLET CHIP |
January 11, 2017 |
December 31, 2020 |
July 1, 2021 |
March 1, 2017 |
December 5, 2017 |
|
- Besançon University Hospital
Besancon, France - Clermont Ferrand University hospital
Clermont-Ferrand, France - Grenoble University Hospital
Grenoble, France - (and 5 more...)
|
| 27 |
NCT03106246 |
Recruiting |
Circulating Extracellular Vesicles Released by Human Islets of Langerhans |
- Type1 Diabetes Mellitus
- Type2 Diabetes
- Islet Cell Transplantation
|
|
Observational |
|
- McGill University Health Center
- CHU de Quebec-Universite Laval
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Determine the levels of circulating EVs
- Determine whether these EVs contain islet-specific antigens
- Mutivariate analysis will be performed with patient parameters and EV parameters
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03106246 |
15-582-MUHC |
|
December 2016 |
December 2018 |
July 2019 |
April 10, 2017 |
April 10, 2017 |
|
- McGill University Health Center
Montreal, Quebec, Canada
|
| 28 |
NCT02872571 |
Recruiting |
Evaluation of the Efficacy of Intramuscular Islet Autograft After Extensive Pancreatectomy |
- Disorder of Endocrine Pancreas
|
- Drug: Intramuscular Islet Autograft
|
Interventional |
Phase 1
Phase 2 |
- University Hospital, Lille
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- the percentage of patients with a functioning graft in the arm 3 months after autograft.
- The percentage of patients with a functioning graft in the arm
- Continuous Glucose Monitoring System
- (and 2 more...)
|
35 |
All |
18 Years and older (Adult, Senior) |
NCT02872571 |
2010_49
2012-A00312-41 |
AUTOGRAFTIM |
April 2013 |
April 2022 |
April 2022 |
August 19, 2016 |
February 2, 2017 |
|
- CHRU, Hôpital Claude Huriez
Lille, France
|
| 29 |
NCT01999374 |
Recruiting |
Long Term Follow up of Recipients of Functional Islet Allografts |
|
|
Observational |
|
- Rodolfo Alejandro
- University of Miami
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Duration of sustained islet allograft function
|
30 |
All |
18 Years to 65 Years (Adult) |
NCT01999374 |
20130034 |
|
March 2013 |
March 2020 |
December 2021 |
December 3, 2013 |
October 9, 2017 |
|
- Diabetes Research Institute
Miami, Florida, United States
|
| 30 |
NCT03259256 |
Recruiting |
Islet Allotransplantation for Type 1 Diabetic Patients |
|
- Procedure: Allogeneic transplantation of intrahepatic islet
|
Interventional |
Phase 3 |
- Second Affiliated Hospital of Guangzhou Medical University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Obtaining an improvement in glycemic control
- normal glycemic control without insulin
- insulin independence
- (and 2 more...)
|
5 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03259256 |
Y-03 |
|
April 23, 2017 |
August 31, 2018 |
June 30, 2019 |
August 23, 2017 |
September 26, 2017 |
|
- The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
|
| 31 |
NCT02000687 |
Recruiting |
Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss |
|
|
Observational |
|
- Rodolfo Alejandro
- University of Miami
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- determine the rate of allosensitization in patients after failed islet transplantation
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02000687 |
20080127 |
|
December 2008 |
December 2020 |
July 2021 |
December 4, 2013 |
October 9, 2017 |
|
- Diabetes Research Institute
Miami, Florida, United States
|
| 32 |
NCT01346098 |
Recruiting |
Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis |
- Postpancreatectomy Hyperglycemia
|
- Procedure: Pancreaticoduodenectomy with pancreatic anastomosis
- Procedure: Total pancreatectomy with islet autotransplantation
|
Interventional |
Phase 2 |
- Ospedale San Raffaele
- Ministry of education, university and research, Italy
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- incidence of complications after pancreatic surgery
- Incidence of each individual postoperative complication
- Incidence of endocrine and exocrine pancreatic insufficiency
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT01346098 |
PAN-IT |
PAN-IT |
July 2010 |
December 2018 |
April 2019 |
May 2, 2011 |
February 9, 2018 |
|
- IRCCS San Raffaele
Milan, Italy
|
| 33 |
NCT01379729 |
Recruiting |
Bet Cell Therapy in Diabetes Type 1 |
|
- Other: Transplantation of encapsulated beta cells.
|
Interventional |
Phase 2 |
- AZ-VUB
- Universitair Ziekenhuis Brussel
- Universitaire Ziekenhuizen Leuven
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT. Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during hyperglycemic clamp at 180 mg/dl.
- Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.
- Changes from Baseline
|
10 |
All |
18 Years to 65 Years (Adult) |
NCT01379729 |
BK_TX_07 |
|
May 2011 |
December 2013 |
May 2018 |
June 23, 2011 |
December 30, 2013 |
|
- UZ Brussel
Brussels, Belgium - UZ Leuven
Leuven, Belgium
|
| 34 |
NCT00678145 |
Recruiting |
Mechanisms Responsible for Hypoglycemia Associated Autonomic Failure |
- Diabetes Mellitus
- Hypoglycemia
- Autonomic Failure
|
- Drug: naloxone
- Dietary Supplement: fructose
- Behavioral: exercise
- (and 2 more...)
|
Interventional |
Phase 2 |
- Albert Einstein College of Medicine, Inc.
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- Change in the counterregulatory responses to hypoglycemia compared to controls
- Symptom scores
|
116 |
All |
18 Years to 55 Years (Adult) |
NCT00678145 |
2012-665
R01DK079974 |
HAAF |
March 2008 |
August 2022 |
August 2022 |
May 15, 2008 |
January 18, 2018 |
|
- Albert Einstein College of Medicine / General Clinical Research Center
Bronx, New York, United States
|
| 35 |
NCT03007017 |
Recruiting |
Novel Strategies for Innovating Deceased Donor Procurement |
|
- Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aorta
- Procedure: Deceased donor nephrectomy, standard of care
|
Interventional |
Not Applicable |
- University of Maryland
- Living Legacy Foundation
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Sequence of organ procurement
- Kidney quality
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03007017 |
00071879 |
|
January 2017 |
December 2019 |
December 2019 |
December 30, 2016 |
December 11, 2017 |
|
- University of Maryland
Baltimore, Maryland, United States
|
| 36 |
NCT02464878 |
Recruiting |
Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant |
- Kidney Transplant
- Type 1 Diabetes
|
- Drug: Alpha 1-Antitrypsin
- Procedure: Islet Transplantation
- Drug: Thymoglobulin
- (and 2 more...)
|
Interventional |
Phase 2 |
- Massachusetts General Hospital
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- University of Iowa
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of GLASSIA versus control CIT06 subjects achieving insulin independence after first infusion of single donor islets.
- Estimated engrafted islet mass by FSIGT at post islet infusion comparing Glassia treated versus control subjects.
- The proportion of GLASSIA treated versus control CIT06 subjects who are insulin independent after 1 or more islet infusions
- (and 21 more...)
|
20 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02464878 |
Islet after Kidney - AAT |
|
January 2017 |
December 2019 |
January 2020 |
June 8, 2015 |
March 21, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 37 |
NCT03415139 |
Not yet recruiting |
Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant |
|
- Drug: Oral Glucose Tolerance Test (OGTT)
|
Observational |
|
- Vanderbilt-Ingram Cancer Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Pre-transplant insulin secretion will be measured as glucose stimulated insulin secretion (GSIS) during a hyperglycemic clamp procedure among patients who do or do not go on to develop PTDM (univariable analysis).
- Pre-transplant insulin secretion will be measured as glucose stimulated insulin secretion (GSIS) during a hyperglycemic clamp procedure among patients who do or do not go on to develop PTDM (multivariable analysis).
- Post-transplant glucagon secretion will be measured during the oral glucose tolerance test among patients who do or do not develop PTDM (univariable analysis).
- (and 3 more...)
|
55 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT03415139 |
VICC BMT 1836 |
|
July 2018 |
April 2023 |
April 2025 |
January 30, 2018 |
March 27, 2018 |
|
- Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
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