Diabetes mellitus
Conditions
Interventions
Experimental group:Human allogeneic islet intraocular transplantation
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient has severe vision loss in at least one eye, with vision below the hand-held level. 2. There is no evidence of progressive or uncontrolled diabetic retinopathy (i.e., proliferative diabetic retinopathy) in the patient. 3. A crystalline eye or a stable intraocular artificial lens in the blind eye. 4. Normal cornea, clear anterior segment. 5. Normal anterior segment anatomy including the iris bed. 6. Male and female subjects aged between 18 and 70 years, without absolute contraindications to surgery. 7. Type 1 or 2 or total/ partial pancreas resection diabetes with severe hypoglycemic events and/or extreme glycemic instability (Type 1 diabetes onset over 5 years, basal and stimulation C-peptide concentrations less than 0.1 nmol/mL, severe glycemic instability or brittle diabetes, frequent hypoglycemia or at least one severe hypoglycemic event in the previous 12 months, severely impaired quality of life related to hypoglycemia, or asymptomatic hypoglycemia (blood glucose 50 mL/min/1.73 m^2 and/or urine protein 5 years at the time of enrollment, sum of patient age and duration of insulin-dependent diabetes = 23. 13. Mixed diet glucose tolerance test (MMTT) in which c-peptide without stimulation is measured at 60 and 90 minutes after starting the diet. (< 0.3 ng/mL) (MMTT; Boost®Plus 6 ml/kg body weight, up to 360 ml; another product with equivalent calories and nutritional components can be used as a substitute for Boost®Plus). 14. Participating in intensive diabetes management, defined as monitoring blood glucose values at least three times a day on average per week, or through continuous glucose monitoring (CGM), injecting insulin three or more times a day or using an insulin pump. This management must be carried out under the guidance of an endocrinologist, diabetes doctor or diabetes specialist, and at least three clinical evaluations must be conducted within 12 months before enrollment in the study. 15. Reduced awareness of hypoglycemia (Clarke score of 4 or above).
Exclusion criteria
Exclusion criteria: 1. Poor visualization of the anterior chamber (corneal opacity, corneal edema, herpes keratitis, etc.) 2. An eye without a lens 3. Narrow angle of the anterior chamber: Spade Scale IV 4. History of glaucoma with the need for surgical intervention (such as trabeculectomy, anterior chamber drainage valve) and uncontrolled glaucoma or neovascular glaucoma 5. History of uveitis 6. Triggered C-peptide > 0.3 ng/ml 7. Clear history of taking drugs that are contraindicated for surgery 8. Body Mass Index (BMI) > 34 kg/m^2 or the patient's weight 1.0 U/kg/day or 10% 11. Blood pressure: SBP > 160 mmHg or DBP > 100 mmHg 12. According to the serum creatinine measured by the subject and the CKD-EPI formula, the GFR of posterior islet transplantation 300 mg/dl) 15. The reactive anti-HLA of islet transplantation after kidney transplant is > 50%. If any of the following situations are detected, the subjects with anti-HLA 130 mg/dL, treated or untreated; and/or fasting triglycerides > 200 mg/dL) 26. Activ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Islet cells successfully engrafted onto the iris, undergoing vascularisation and nerve growth, thereby establishing functional islet organ formation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The transplanted islets successfully stabilised the patient's blood glucose levels.;Subjects did not experience any significant decline in visual acuity.;Subjects did not exhibit a marked increase in intraocular pressure.; | — |
Countries
China
Contacts
Public ContactMeixia Zhang
West China Hospital, Sichuan University
Outcome results
None listed