18 Years to 68 Years
Accepting Healthy Volunteers?
- Male and female subjects age 18 to 68 years.
- Subjects who are able to provide written informed consent and to comply with the
procedures of the study protocol.
- Clinical history compatible with T1D with disease onset < 40 years of age and
insulin-dependence for > 5 years at the time of enrollment, and a sum of subject age
and insulin dependent diabetes duration of > 28.
- Absent stimulated c-peptide (< 0.3 ng/mL) in response to a MMTT [Boost® 6 mL/kg body
weight (BW) to a maximum of 360 mL; another product with equivalent caloric and
nutrient content may be substituted for Boost®] measured at 60 and 90 min after start
- Subjects who are > or at 3 months post-renal 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)or subject will receive islets transplant within 72hours after
kidney transplantation (islets and kidney are from the same donor)
- Stable renal function as defined by a creatinine of no more than one third greater
than the average creatinine determination performed in the 3 previous months prior to
islet transplantation, until rejection, obstruction or infection is ruled out.
- Weight more than 90 kg or body mass index (BMI) > 30 kg/m2.
- Insulin requirement of >1.0 IU/kg/day or <15 U/day.
- Other (non-kidney) organ transplants except prior failed pancreatic graft where the
graft failed within the first two weeks due to thrombosis, followed by pancreatectomy;
with the pancreas transplant occurring more than 6 months prior to enrollment.
- Untreated or unstable proliferative diabetic retinopathy.
- Blood Pressure: SBP > 160 mmHg or DBP >100 mmHg despite treatment with
- Calculated GFR < 40 mL/min/1.73 m2 using the subject's measured serum creatinine and
the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation . Strict
vegetarians (vegans) will be excluded only if their estimated GFR is < 35 mL/min/1.73
- Proteinuria (albumin/ creatinine ratio or ACr > 300mg/g) of new onset since kidney
- Either Class I or Class II panel-reactive anti-HLA antibodies > 50%. Subjects with
either Class I or Class II panel reactive anti-HLA antibodies >50% will be excluded if
any of the following are detected: Positive cross-match, Islet donor-directed 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, or Antibodies to
the renal donor (i.e. presumed de novo).
- 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.
- Presence or history of active infection including hepatitis B, hepatitis C, HIV, or
tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded
even in the absence of clinical evidence of active infection.