None listed
Conditions
Brief summary
The aim of this pilot study is to examine the efficacy of transplanting encapsulated human islets into individuals with type 1 diabetes in the absence of anti-rejection drugs.
Interventions
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.
Sponsors
South Eastern Sydney Illawarra Area Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed