B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure
1 other identifier
expanded_access
N/A
1 country
1
Brief Summary
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Trial Health
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedJune 11, 2014
June 1, 2014
January 12, 2010
June 9, 2014
Conditions
Keywords
Interventions
200mL sterile suspension of allogeneic human pancreatic islets
Dosed to maintain whole blood 24-hr trough levels 10-15ng/mL for first 3 months and 8-12ng/mL thereafter daily. Sirolimus is used to prevent transplant rejection.
20mg intravenously (IV) 2hrs prior to islet infusion and on Day 4 post-transplant. Basiliximab is used to prevent transplant rejection
Initial dose of 0.015mg/kg p.o. daily on Day 1 post transplant, and adjusted to maintain 12-hr trough levels 3-6ng/mL. Tacrolimus lowers the risk of organ rejection
Broad spectrum antimicrobial prophylaxis administered preoperatively
80mg/400mg by mouth once a day starting on Day 1 for duration of the study follow-up. This medication is used to prevent bacterial infections.
1 troche by mouth 4 times daily starting two days prior to transplant until 3 months after the transplant. This medication is used to prevent fungal infections.
450mg dose by mouth once a day starting two days pre-transplant and increasing to 900 mg once a day by Day 12 and continuing for 14 weeks post-transplant. This medication is used to prevent cytomegalovirus infections.
70U/kg body weight of recipient given with islet infusion, followed by 3U/kg/hr for the next 4hrs. From 5th through 48th hr post-transplant heparin will be titrated to achieve and maintain a Partial Thromboplastin Time (PTT) of 50-60 seconds. This medication is used to prevent the formation of blood clots.
30mg subcutaneously twice a day from 48 hrs post-transplant through Day 7 post-transplant. This medication is used to prevent the formation of blood clots.
400mg slow release tablet by mouth three times a day beginning 2 days prior to transplant and continue for 7 days post transplant. This medication improves blood flow.
81mg enteric coated aspirin by mouth every night, starting 24hrs post-transplant. This medication prevents blood clots.
Eligibility Criteria
You may qualify if:
- Enrolled in clinical trial DAIT CIT-05 (NCT00468442)
- Islet graft failure: absent stimulated C-peptide (\<0.3ng/mL) in response to mixed meal tolerance test
You may not qualify if:
- Untreated proliferative diabetic retinopathy
- Blood Pressure: systolic blood pressure\>160mmHg or diastolic blood pressure\>100mmHg
- Measured glomerular filtration rate (GFR) using iohexol \< 80ml/min/1.73m\^2 Strict vegetarians with a calculated GFR \< 70ml/min/1.73m\^2
- Presence or history of macroalbuminuria \> 300mg/g of creatinine
- Presence or history of panel-reactive anti-HLA antibodies above background by flow cytometry
- For female participants: Positive Pregnancy Test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3 months after discontinuation. For male participants: intent to procreate during the duration of the study or within 3 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 as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. Positive tests are otherwise not acceptable, even in the absence of any active infection at the time of evaluation.
- Negative screen for Epstein-Barr Virus (EBV) by IgG determination
- Invasive aspergillus, histoplasmosis, or coccidiomycosis infection within one year prior to study enrollment
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- Known active alcohol or substance abuse
- Anemia (Hgb \< 11 g/dL),neutropenia (\<1,500/µL), or thrombocytopenia (platelets \<100,000/µL)
- A history of Factor V deficiency
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or patients with an International Normalized Ratio (INR) \>1.5
- Severe co-existing cardiac disease, characterized by any one of these conditions:
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2010
First Posted
January 14, 2010
Last Updated
June 11, 2014
Record last verified: 2014-06