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Trial registered on ANZCTR


Registration number
ACTRN12609000192280
Ethics application status
Approved
Date submitted
1/04/2009
Date registered
20/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Encapsulated islets as a therapy for type 1 diabetes
Scientific title
Safety and Function of Encapsulated Human Islets Transplanted Into People With Diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 4552 0
Condition category
Condition code
Metabolic and Endocrine 4844 4844 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Islets inside microcaspules, made from alginate that is extracted from seaweed, are infused into the peritoneal cavity to overcome the need for exogenous insulin administration. Up to 4 infusions are carried out per patient, with each infusion the maximum number of islets obtained from a human pancreas donated after death. Average is 178,200 islet equivalents per infusion.
Intervention code [1] 4317 0
Treatment: Devices
Comparator / control treatment
The patients are their own controls. All are C-peptide negative, so any production of C-peptide must be a result of the transplant. Glycaemic control and insulin requirments post transplant are compared with individual patient values pre-transplantation.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5702 0
To normalize blood glucose levels in people with type 1 diabetes patients and no previous evidence of beta cell function, without the need for exogenous insulin.

Method used for assessment:
1. Blood glucose monitoring by patients
2. Daily exogenous insulin requirements.
Timepoint [1] 5702 0
Daily for up to 12 months after islet infusion
Secondary outcome [1] 241615 0
The dynamics of insulin production from the grafted cells. This is assessed in two ways:
1. 24 hour urinary C-peptide and creatinine (C-peptide index = 100 x [C-peptide (pmol/mL)] / [creatinine (mol/mL)]. All patients are initially C-peptide negative.
2. serum C-peptide after 5g intravenous arginine up to 12 months, or longer if there is insulin production from the graft
Timepoint [1] 241615 0
Urinary C-peptide: at 1,3 & 5 days, 1, 2, 3 & 4 weeks, 2,3, 4 5, 6 8,10,12, and 3 monthly thereafter if the graft is functioning. Each time point relates to time from each islet infusion.
Arginine stimulation test: at 1 week, 1, 3, 6, 12, 18 & 24mo, yearly thereafter, if the graft is functioning.
Final endpoint is October 2008, a total of 33 months after the first infusion.
Secondary outcome [2] 241733 0
Safety
(a) the safety of injecting encapsulated human islets into people with type 1 diabetes (pain and infection are the assessment criteria)
(b) if cytotoxic antibodies are produced
(c) if there is recurrence of autoimmune activation
Timepoint [2] 241733 0
(a) Safety of injecting encapsulated islets: on day of infusion and daily over the next week.
(b) cytotoxic antibodies: monthly
(c) islet cell antibodies: at 1 week, 1, 3, 6, 12, 18 & 24mo, yearly thereafter, if the graft is functioning.
Final endpoint is October 2008, a total of 33 months after the first infusion.

Eligibility
Key inclusion criteria
normal body weight, that is, body mass index < 30, but ideally <25.
(b) age 18-50 years
(c) no insulin production from their pancreas
(d) (i) difficulty in controlling blood glucose levels despite compliance with insulin injections, physical activity and food intake. This difficulty is impacting on the quality of life.
(ii) unable to recognise the symptoms of low blood glucose levels for whom no other strategy has been successful.
(iii) special situations, e.g., rapid falls in blood glucose levels resulting in epilepsy and where anti-epileptic medication is unsuitable.

Each case will be considered on its merit, but the benefit must exceed the risk.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Does not fit the above criteria.
2. Residual function of recipient’s pancreatic beta cells, as assessed by C-peptide production.
3. Body mass index > 30.
4. Pregnancy.
5. Non-agreement by patient’s endocrinologist.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4742 0
Self funded/Unfunded
Name [1] 4742 0
Country [1] 4742 0
Primary sponsor type
Government body
Name
South Eastern Sydney Illawarra Area Health Service
Address
Research Office, Prince of Wales Hospital, High Street, Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 4281 0
None
Name [1] 4281 0
Address [1] 4281 0
Country [1] 4281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6783 0
South Eastern Sydney Illawarra Area Health Service Human Research Ethics Committee, Northern Division
Ethics committee address [1] 6783 0
Ethics committee country [1] 6783 0
Australia
Date submitted for ethics approval [1] 6783 0
Approval date [1] 6783 0
28/06/2005
Ethics approval number [1] 6783 0
05/151

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29457 0
Address 29457 0
Country 29457 0
Phone 29457 0
Fax 29457 0
Email 29457 0
Contact person for public queries
Name 12704 0
Ms Nola Camden
Address 12704 0
c/- Diabetes Transplant Unit, Prionce of Wales Hospital, High Street, Randwick, NSW 2031
Country 12704 0
Australia
Phone 12704 0
+61 409 652 650
Fax 12704 0
Email 12704 0
nolies@gmail.com
Contact person for scientific queries
Name 3632 0
Dr Bernie Tuch
Address 3632 0
P.O. Box 821, Maroubra, NSW 2035
Country 3632 0
Australia
Phone 3632 0
+61 411 461 604
Fax 3632 0
Email 3632 0
btuch@alumni.sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISafety and Viability of Microencapsulated Human Islets Transplanted Into Diabetic Humans2009https://doi.org/10.2337/dc09-0744
EmbasePaving the way for successful islet encapsulation.2019https://dx.doi.org/10.1016/j.drudis.2019.01.020
EmbasePluripotent stem cells as a therapy for type 1 diabetes.2023https://dx.doi.org/10.1016/bs.pmbts.2023.03.001
N.B. These documents automatically identified may not have been verified by the study sponsor.