NCT03259256|UnknownPhase 3
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Sponsor study identifier
interventional
5
1 country
1
Study Start
April 23, 2017
Actual (reported)Primary Completion
August 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine if islet cell transplantation , is an effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 23, 2017
Actual (reported)August 19, 2017
Actual (reported)August 23, 2017
Actual (reported)August 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Obtaining an improvement in glycemic control
The proportion of subjects with an HbA1c ≤ 6.5% and free of severe hypoglycemic events
nine months after first and last islet transplants
normal glycemic control without insulin
A fasting glucose (\> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months
3 months after graf
insulin independence
One year after the last transplant
Hypoglycemic episodes by HYPO score
3 months after transplantation
degenerative complications of diabetes
18 months after transplantation
Each subject may receive 1-3 transplantations of allogeneic human islets we will inject the least dose of 3,000 IEQ/kg body weight of the recipient. Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml.
Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
ping Xue, PhD
Second Affiliated Hospital of Guangzhou Medical University
First Submitted
August 19, 2017
First Posted
August 23, 2017
Study Start
April 23, 2017
Actual (reported)Primary Completion
August 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
June 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 26, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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