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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier:
NCT00315614
First received: April 14, 2006
Last updated: April 16, 2014
Last verified: March 2014
Results First Received: December 20, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Intervention: Drug: Islet Transplantation

  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
No text entered.

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 CD34 Bone Marrow Islet Transplantation: Islet transplantation

Participant Flow:   Overall Study
    Islet Transplantation and CD34 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  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     3  



  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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Primary:   The Induction of Multilineage Chimerism   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Insulin Independence or Reduction in Exogenous Insulin Requirements (Partial Graft Function), as Evidenced by Basal C-peptide Greater Than 0.5 ng/ml Prior to Weaning of Immunosuppression;   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Improvement in Metabolic Control as Evidenced by Improvement in:   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   HbA1C (Should be < 6.5%),   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Mean Amplitude of Glycemic Excursions (MAGE),   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Mean Glucose Meter Readings,   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   CGMS (Continuous Glucose Monitoring System)   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Elimination or Reduction in the Incidence of Hypoglycemic Coma or Unawareness;   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Improvement in or Decreased Progression of Microvascular, Macrovascular and Neuropathic Complications of Diabetes.   [ Time Frame: for the duration of islet graft function ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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


No publications provided by University of Miami

Publications automatically indexed to this study:

Responsible Party: Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier: NCT00315614     History of Changes
Other Study ID Numbers: 2000/0024, R01DK056953
Study First Received: April 14, 2006
Results First Received: December 20, 2013
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration