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Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant

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.
 
ClinicalTrials.gov Identifier: NCT00788827
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 1 Diabetes
Type 2 Diabetes
Intervention Biological: Autologous CD34+ stem cells
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autologous CD34+ Stem Cells
Hide Arm/Group Description

Up to 5 x 10 log 8 of autologous stem cells on a single occasion

Autologous CD34+ stem cells: Up to 5 x 10 log 8 of autologous stem cells on a single occasion

Period Title: Overall Study
Started 7
Completed 5
Not Completed 2
Reason Not Completed
Lack of Efficacy             2
Arm/Group Title Single Arm
Hide Arm/Group Description Autologous CD34+ Stem Cells
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
54.6  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
2
  28.6%
Male
5
  71.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 7 participants
7
1.Primary Outcome
Title Number of Participants Who Experienced Adverse Events
Hide Description Safety will be evaluated in terms of adverse events graded according to CTCTAE toxicity criteria and laboratory test results. All adverse events will also be graded for relationship to treatment and as expected and unexpected.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous Stem Cells
Hide Arm/Group Description:

Up to 5 x 10 log 8 of autologous stem cells on a single occasion

Autologous CD34+ stem cells: Up to 5 x 10 log 8 of autologous stem cells on a single occasion

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Haematoma at femoral catheter insertion 1
Fatigue 7
2.Secondary Outcome
Title Hba1C Data of Pre and Post Stem Cell Infusion
Hide Description Mean HbA1c laboratory measurements pre and post stem cell infusion
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were infused with stem cells
Arm/Group Title Pre Infusion of Stem Cells Post Infusion of Stem Cells
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Before the infusion of stem cells
After the infusion of stem cells
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: percentage
7.2  (1.3) 7.24  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pre Infusion of Stem Cells, Post Infusion of Stem Cells
Comments Each participants Hba1c (%) lab result was analysed pre and post stem cell infusion to achieve 2 mean readings per participant.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Insulin Level
Hide Description Mean insulin requirement was calculated for each participant pre and post stem cell infusion
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received a stem cell infusion
Arm/Group Title Pre Infusion of Stem Cells Post Infusion of Stem Cells
Hide Arm/Group Description:
Before the infusion of stem cells
After the infusion of stem cells
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: iu/day
59.4  (25.7) 54.06  (18.2)
4.Secondary Outcome
Title Amylase Level
Hide Description Each participant had mean amylase data analysed to give a pre and post mean result
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received a stem cell infusion
Arm/Group Title Pre Infusion of Stem Cells Post Infusion of Stem Cells
Hide Arm/Group Description:
Before the infusion of stem cells
After the infusion of stem cells
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units/L
48.49  (25.2) 75.52  (34.2)
5.Secondary Outcome
Title Serum Creatinine
Hide Description Each participant had serum creatinine analysis pre and post stem cell infusion to give mean result
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received stem cell infusion
Arm/Group Title Pre Infusion of Stem Cells Post Infusion of Stem Cells
Hide Arm/Group Description:
Before the infusion of stem cells
After the infusion of stem cells
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: umol/L
128.22  (11.9) 118.64  (15.5)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description Autologous stem cells
All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   0/7 (0.00%)    
Hide Serious Adverse Events
Single Arm
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Blood and lymphatic system disorders   
Haemotoma  1  1/7 (14.29%)  1
Nervous system disorders   
Fatigue * 1  7/7 (100.00%)  7
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Charles Pusey
Organization: Imperial College London
Phone: +44 3313 2308
EMail: c.pusey@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00788827    
Other Study ID Numbers: HHSC 005
CRO0472 ( Other Identifier: Imperial College London )
First Submitted: November 10, 2008
First Posted: November 11, 2008
Results First Submitted: July 26, 2019
Results First Posted: November 18, 2019
Last Update Posted: November 18, 2019