Type 1 Diabetes MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Product Name: Low molecular weight dextran sulfate
Product Code: LMW-DS
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: LMW-DS
Other descriptive name: Dextran sulfate
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID), NIH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients between 18 to 65 years of age. 2 Subjects who are able to provide written informed consent and comply with the procedures of the study protocol. 3. Clinical history compatible with type 1 diabetes with onset of disease at 28. 4. Absent stimulated c-peptide =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known IgE mediated allergy to antibiotics and antifungal medications (ciprofloxacin,gentamycin amfoteracin B) used in the culture medium. 2. Known hypersensitivity to dextran. 3. Body mass index (BMI) >30kg/m^2. 4. Insulin requirement of >1.0 IU/kg/day. 5. HbA1c >10%. 6. Untreated proliferative diabetic retinopathy. 7. Blood Pressure SBP >160 mmHg or DBP >100 mmHg. 8. Measured glomerular filtration rate (GFR) using 51Cr-EDTA, 99technetium-DPTA, or iohexol 1.73^2 9. Presence or history of macroalbuminuria (>300mg /g creatinine). 10. Presence or history of panel-reactive anti-HLA antibodies >80% by flow cytometry. * 11. 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. 12. Active infection including hepatitis B, hepatitis C or HIV. 13. Negative screen for Epstein-Barr Virus (EBV) by IgG determination. 14. Any history of malignancy. * 15. Known active alcohol or substance abuse. 16. Baseline Hgb below the lower limits of normal at the local laboratory; lymphopenia (1.5. 19. Known history of severe co-existing cardiac disease. * 20. Consistently abnormal liver function tests at the time of study entry.* 21. Acute or chronic pancreatitis. 22. Patients with active peptic ulcer disease, symptomatic gallstones, or a history of portal hypertension. 23. Severe unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications. 24. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of =5mg prednisone daily, or an equivalent dose of hydrocortisone, only for physiological replacement. 25. Treatment with any anti-diabetic medication, other than insulin, within 4 weeks of enrollment. 26. Use of any investigational agents within 4 weeks of enrollment. 27. Administration of live attenuated vaccine(s) within 2 months of enrollment. 28. Patients with any condition or any circumstances that in the opinion of the investigator would make it unsafe to undergo an islet transplant. 29. Treatment with any immunosuppressive regimen at the time of enrollment. 30. A previous islet transplant. 31. A previous pancreas transplant, unless the graft failed within the first week due to thrombosis, followed by pancreatectomy and the transplant occurred more than 6 months prior to enrollment. * Please refer to study protocol for further details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of Low Molecular Weight Dextran Sulfate (LMW-DS) to enhance engraftment and prevent IBMIR in islet transplantation to Type 1 diabetic subjects. ;Secondary Objective: To gather additional safety and efficacy information about the combination of Low Molecular Weight Sulfated Dextran with islet transplantation. ;Primary end point(s): The level of stimulated c-peptide at 90 minutes derived from the mixed-meal tolerance test (MMTT) at 75±5 days following the first islet infusion. | — |
Countries
Sweden
Outcome results
None listed