Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes
The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence.
Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Diabetes in the Intra-Muscular Site
Single-center, open label, non-randomized safety and efficacy trial to evaluate co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression.
A total of 8 patients will be enrolled in the study and followed for a minimum of 1 year up to 2 years after the last islet transplant, depending on enrollment date.
Type 1 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 1 Co-transplantation of PTG with pancreatic islets
You can join if…
Open to people ages 18-70
- Male and female subjects age 18 to 70 years of age.
- Subjects who are able to provide written informed consent and to comply with study procedures.
- Clinical history compatible with Type 1 diabetes (onset < 40 yrs old and insulin dependent for > 5 yrs at enrollment, c-peptide negative).
- Recipients should have absent stimulated c-peptide (< 0.3 ng/mL) in response to a (Boost® 6 mL/kg BW to a maximum of 360 mL; another equivalent product), measured at 60 and 90 min after start of consumption.
- Subjects who are > 6 months post-renal transplant or >6 months post-liver transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression ([tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic, or azathioprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic ± Prednisone ≤ 10 mg/day).
- Stable renal function as defined by a creatinine of no more than one third greater than the average creatinine determination performed in the 6 previous months prior to islet transplant, as well as absence of a rejection episode in the 6 months prior to islet transplant
- Stable liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values < 1.5, or total bilirubin < 1.5 times normal upper limits at time of study entry, as well as absence of a rejection episode in the 6 months prior to islet transplant
You CAN'T join if...
- Presence of donor specific anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross match
- Insulin requirement of >1.0 IU/kg/day
- Weight more than 100 kg or body mass index (BMI) > 30 kg/m2.
- Primary hyperparathyroidism OR secondary hyperparathyroidism
- Untreated or unstable proliferative diabetic retinopathy.
- Blood Pressure: SBP > 180 mmHg or DBP >100 mmHg despite treatment with antihypertensive agents.
- Calculated GFR of ≤ 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) equation, as well as presence of a rejection episode in the 6 months prior to islet transplant
- Elevated liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values > 1.5, or total bilirubin >1.5 times normal upper limits at time of study entry, as well as presence of a rejection episode in the 6 months prior to islet transplant
- Proteinuria (albumin/creatinine ratio or ACr > 300mg/g) of new onset since kidney transplantation.
- . For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo- Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
- . Active infection including hepatitis B, hepatitis C, HIV, or TB. A positive skin test (PPD) in itself is not an exclusion and will be followed up by a Quantiferon gold assay.
- . Negative screen for EBV IgG.
- . Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within 1 year prior to study entry.
- . Any history of malignancy following receiving either the kidney or liver transplant, except for completely resected squamous or basal cell carcinoma of the skin
- . Known active alcohol or substance abuse.
- . Severe co-existing cardiac disease, characterized by any one of these conditions:
- Recent MI (within past 6 months),
- Evidence of ischemia on functional cardiac exam within the last year,
- Left ventricular ejection fraction < 30%,
- Valvular disease requiring replacement with prosthetic valve.
- . Active infections (except mild skin and nail fungal infections).
- . Active peptic ulcer disease or gastritis, symptomatic gallstones, or portal hypertension.
- . Use of any investigational agents within 4 weeks of enrollment.
- . Administration of live attenuated vaccine(s) within 2 months of enrollment.
- . Any medical condition that, in the opinion of the investigator, will interfere with safe study completion.
- . Positive screen for BK viremia at time of screening.
- . Untreated hyperlipidemia - TC > 200 mg/dL, TGC > 200 mg/dL, LDL > 130 mg/dL
- University of California
accepting new patients
San Francisco California 94143 United States
Lead Scientist at UCSF
- Peter Stock, MD, PhD
Professor, Surgery. Authored (or co-authored) 236 research publications.
- accepting new patients
- Start Date
- Completion Date
- Peter Stock
- Phase 1/2
- Study Type
- Last Updated
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