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Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus

This study has been terminated.
(We did not achieve a tolerogenic profile. Subjects withdrew from protocol and enrolled in other islet transplant trials.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315614
First Posted: April 18, 2006
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Research Institute Foundation
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami
Results First Submitted: December 20, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Intervention: Biological: Islet Transplantation and Bone Marrow

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Islet Transplantation and Bone Marrow Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.

Participant Flow:   Overall Study
    Islet Transplantation and Bone Marrow
STARTED   3 
COMPLETED   3 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Islet Transplantation and CD34 Bone Marrow Islet Transplantation: Islet transplantation

Baseline Measures
   Islet Transplantation and CD34 Bone Marrow 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  66.7% 
Male      1  33.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Achievement of Persistent Islet Function Following Cessation of Immunosuppression.   [ Time Frame: for the duration of islet graft function ]

2.  Primary:   A Reduction or Absence of Rejection Episodes   [ Time Frame: for the duration of islet graft function ]

3.  Secondary:   Number of Subjects With Basal C-peptide Greater Than 0.5 ng/ml   [ Time Frame: for the duration of islet graft function ]

4.  Secondary:   Number of Subjects With Reduction of Severe Hypoglycemia and Improvement in Hypoglycemia Awareness   [ Time Frame: for the duration of islet graft function ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rodolfo Alejandro
Organization: University of Miami
phone: 3052435324
e-mail: ralejand@med.miami.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier: NCT00315614     History of Changes
Other Study ID Numbers: 2000/0024
R01DK056953 ( U.S. NIH Grant/Contract )
First Submitted: April 14, 2006
First Posted: April 18, 2006
Results First Submitted: December 20, 2013
Results First Posted: February 10, 2014
Last Update Posted: April 4, 2017