Islet Isolation Using MnTE-2-PyP (BMX-010) - Pilot Study

Inclusion Criteria: To be eligible the participant must have had type 1 diabetes mellitus (T1DM) for more than 5 years, complicated by at least 1 of the following situations that persist despite intensive insulin management efforts: * a. Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels \< 3.0 mmol/L, indicated by, 1 or more episodes of severe hypoglycemia requiring third party assistance within 12 months, a Clarke score ≥4, HYPO score ≥1,000, lability index (LI) ≥400 or combined HYPO/LI \>400/\>300. * b. Metabolic instability, characterized by erratic blood glucose levels that interfere with daily activities and or 1 or more hospital visits for diabetic ketoacidosis over the last 12 months. * Participants must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent. Exclusion Criteria: * 1\. History of enrollment in any other islet transplant trials (at the discretion of the investigator). * 2\. Severe co-existing cardiac disease, characterized by any one of these conditions: (a) recent (within the past 6months) myocardial infarction; (b) left ventricular ejection fraction \<30%; or (c) evidence of ischemia on functional cardiac exam. * 3\. Active alcohol or substance abuse, to include cigarette smoking (must be abstinent for 6 months prior to listing for transplant). * 4\. Psychiatric disorder making the subject not a suitable candidate for transplantation, (e.g., schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medication). * 5\. History of non-adherence to prescribed regimens. * 6\. Active infection including Hepatitis C, Hepatitis B, HIV, or TB (subjects with a positive PPD performed within one year of enrollment, and no history of adequate chemoprophylaxis). * 7\. Any history of, or current malignancies except squamous or basal skin cancer. * 8\. BMI \> 35 kg/m2 at screening visit. * 9\. Age less than 18 or greater than 68 years. * 10\. Measured glomerular filtration rate (GFR) \<60 mL/min/1.73 m2. * 11\. Presence or history of macroalbuminuria (\>300 mg/g creatinine). * 12\. Clinical suspicion of nephritic (hematuria, active urinary sediment) or rapidly progressing renal impairment (e.g. Increase in serum creatinine of 25% within the last 3-6 months). * 13\. Baseline Hb \< 105g/L (\<10.5 g/dL) in women, or \< 120 g/L (\<12 g/dL) in men. * 14\. Baseline screening liver function tests outside of normal range, with the exception of uncomplicated Gilbert's Syndrome. An initial LFT panel with any values \>1.5 times the upper limit of normal (ULN) will exclude a patient without a re-test; a re-test for any values between ULN and 1.5 times ULN should be made, and if the values remain elevated above normal limits, the patient will be excluded. * 15\. Untreated proliferative retinopathy. * 16\. Positive pregnancy test, intent for future pregnancy or male subjects' intent to procreate, failure to follow effective contraceptive measures, or presently breast-feeding. * 17\. Evidence of significant sensitization on PRA (at the discretion of the investigator). * 18\. Insulin requirement \>1.0 U/kg/day * 19\. HbA1C \>12%. * 20\. Uncontrolled hyperlipidemia \[fasting LDL cholesterol \> 3.4 mmol/L (133 mg/dL), treated or untreated; and/or fasting triglycerides \> 2.3 mmol/L (90 mg/dL)\]. * 21\. Under treatment for a medical condition requiring chronic use of steroids. * 22\. Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT/INR \> 1.5. * 23\. Untreated Celiac disease. * 24\. Patients with Graves disease will be excluded unless previously adequately treated with radioiodine ablative therapy.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.