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Pancreatic Islet Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00214786
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : June 6, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Baylor Health Care System
University of Miami
Information provided by (Responsible Party):
Baylor Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Biological: Islet cell transplantation
Enrollment 4
Recruitment Details Recruitment period took place between April 2003 thru November 2005. Consent took place in the transplant clinic at Baylor University Medical Center (BUMC).
Pre-assignment Details Patients signed informed consent after a consultation visit with tyhe PI. Then they proceeded through the evaluation phase of the study. During this phase, some patients were excluded based off of clinical findings (i.e. lab reports or procedures that did not meet protocol standards).
Arm/Group Title Islet Cell Transplantation
Hide Arm/Group Description Patients who received islet cell transplantation. The recipients will be given islet cell preparation with more than 4000 Islet Equivalent (IE)/kg for multiple times up to 3 infusions.
Period Title: Overall Study
Started 4
Completed 1
Not Completed 3
Arm/Group Title Islet Cell
Hide Arm/Group Description Patients with allogeneic islet cell transplantation
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
35.5  (11.56143)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Achievement of Insulin Independence at 12-month Post Transplant
Hide Description To assess the number of patients who achieve insulin independence at 12-month after islet cell transplantation
Time Frame 12 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participant
1
2.Secondary Outcome
Title Presence or Absence of Hypoglycemic Unawareness
Hide Description Number of patients who achieved absence of hypoglycemic unawareness
Time Frame 12 months after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
3
3.Secondary Outcome
Title Incidence of Hypoglycemic Episodes
Hide Description Blood glucose <70 mg/dl, number of times reported per month
Time Frame 12 months after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 4
Mean (Standard Error)
Unit of Measure: episodes per month
7.3  (2.5)
4.Secondary Outcome
Title Change of Insulin Requirements in Patients Who Did Not Become Insulin Independent
Hide Description Percentage of insulin requirement at month 12 against that at baseline in the patients who did not achieve insulin independence. The percentage less than 100% indicates that subjects reduced insulin requirements 12 months after islet transplantation when compared with those at pre-transplant, while the parentage more than 100% represents that patients needed higher amount of exogenous insulin 12 months after islet transplantation.
Time Frame 12 months after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 3
Mean (Standard Error)
Unit of Measure: Percent decrease compared to baseline
34.3  (10.5)
5.Secondary Outcome
Title Islet Cell Mass Obtained After Remote Site Processing
Hide Description The sum of Islet mass obtained after transport using the two-layer preservation method, remote site processing and islet culture. Islet mass as defined by Islet Equivalent per kilogram recipient body weight.
Time Frame At transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 4
Mean (Standard Error)
Unit of Measure: Islet Equivalent per kilogram
8717  (2243)
6.Secondary Outcome
Title The Number of Islet Cell Infusions Needed to Achieve Insulin Independence
Hide Description [Not Specified]
Time Frame 12 months after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 1
Mean (Standard Error)
Unit of Measure: number of infusion
2  (0)
7.Secondary Outcome
Title Renal Function
Hide Description Glomerular filtration rate measured by sodium iothalamate I-125 injection (GLOFIL)
Time Frame 12 months after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 4
Mean (Standard Error)
Unit of Measure: ml/min
127.3  (7.9)
8.Secondary Outcome
Title Morbidity Related to the Immunosuppression Regimen
Hide Description Number of participants who experienced serious adverse events related to immunosuppression regimen
Time Frame 12 months after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participant
2
9.Secondary Outcome
Title Morbidity Related to the Islet Cell Infusion
Hide Description Number of participants who experienced serious adverse events related to islet cell infusion
Time Frame 12months after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participant
3
10.Secondary Outcome
Title The Quality of Life of the Recipients Measured With the RAND 36-item Short Form Health Survey
Hide Description Averaged score in subscales of 'physical functioning', 'Role limitations due to emotional problems', 'energy/fatigue', 'emotional well-being', 'social functioning', 'pain' and 'general health' in the RAND 36-item short form health survey (SF-36). Full scale range is 0-100 for all subscales with 100 as the best outcome and 0 as the worst outcome.
Time Frame 12 months after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Islet Cell
Hide Arm/Group Description:
Allogeneic Islet Cell Transplantation
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: Scores on a scale
79.6
(57.8 to 88.8)
Time Frame 12 months after transplantation
Adverse Event Reporting Description The number of adverse events which was observed within 12 months after transplantation
 
Arm/Group Title Islet Cell
Hide Arm/Group Description Patients with allogeneic islet cell transplantation
All-Cause Mortality
Islet Cell
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Islet Cell
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Gastrointestinal disorders   
Nausea and Vomiting  [1]  1/4 (25.00%)  1
Abdominal Pain   1/4 (25.00%)  1
Hepatobiliary disorders   
Elevated Liver Function Tests  [2]  4/4 (100.00%)  4
Respiratory, thoracic and mediastinal disorders   
Pneumonia   1/4 (25.00%)  1
Indicates events were collected by systematic assessment
[1]
Patient experienced N & V which the PI determined was related to the protocol stated immunosuppressive medications.
[2]
Three patients had elevated liver function tests post transplant and 1 patient had gallbladder hemorrhage.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Islet Cell
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Gastrointestinal disorders   
nausea and vomiting *  4/4 (100.00%)  4
Skin and subcutaneous tissue disorders   
mouth ulcer *  4/4 (100.00%)  4
*
Indicates events were collected by non-systematic assessment
Three of the four patients voluntarily withdrew from the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Marlon Levy
Organization: Baylor University Medical Center
Phone: 214-820-2050
EMail: Marlon.Levy@baylorhealth.edu
Layout table for additonal information
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00214786     History of Changes
Other Study ID Numbers: 003-040
First Submitted: September 14, 2005
First Posted: September 22, 2005
Results First Submitted: February 11, 2013
Results First Posted: June 6, 2014
Last Update Posted: June 14, 2017