I just received this email and I don’t see it up on their website yet, so I’ll copy the contents below. Maybe the JDRF will get wind of this while they work feverishly towards our “artificial pancreas” project. (/sarcasm)
DIABECELL® is LCT’s encapsulated insulin-producing porcine pancreatic islet cells.
To date, seven patients with insulin dependent diabetes have received between one and three implants of DIABECELL® without remarkable adverse events in LCT’s on-going Phase I/IIa clinical trial.
LCT Medical Director, Professor Bob Elliott, who is in San Diego, USA, delivering a plenary lecture on DIABECELL® at the Annual Meeting of the International Society for Cell Therapy, said, "Having two patients going off their insulin injections gives me tremendous confidence that we have a treatment which can return people with diabetes to a normal life.
All patients followed-up show improvement of diabetes control with better glycated haemoglobin (%HbA1c) levels. I am extremely pleased to see all blood glucose levels in their seven-point recordings to be in the normal range, even with a lower daily dose of insulin."
LCT CEO, Dr Paul Tan added, “The dose escalation and the tightening of the quality specifications of DIABECELL® for the last two implants have led to a very satisfying outcome with the recipients becoming insulin independent and we look forward to an equally positive outcome for future patients. LCT expects DIABECELL® to be established as a product of exceptional commercial value”.
Progress Report of DIABECELL® Phase I/IIa Clinical Trial
The trial is an open labelled Phase I/IIa investigation to obtain data on the safety and preliminary efficacy of DIABECELL®, encapsulated neonatal porcine pancreatic islets, without the use of immunosuppressive drugs.
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The trial started in Moscow in 2007 and is intended to enrol a total of 10 patients with type 1 diabetes who have given informed consent for their participation. The trial is being monitored by Geny Research Group Inc, a U.S.-based contract research organization.
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To date, seven insulin dependent diabetes patients have been implanted:
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The trial was designed for Patients #1 - #5 to receive two implants of DIABECELL® at the dose of 5,000 Islet Equivalents per kg body weight (IEQ/kg) at least 6 months apart and for Patients #6 - #10 to receive one implant of 10,000 IEQ/kg.
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Based on clinical assessment, amendments to the protocol were requested by the investigators to optimise the treatment in this dose-finding study. Patients #3, #4 and #5 received implants of 5,000 and 10,000 IEQ/kg. Patient #2 received a third implant of 10,000 IEQ/kg.
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As summarised in the following Table, patients have been followed up from a minimum of 18 weeks to 96 weeks. Patient #6 failed to attend follow up after 20 weeks and attempts to resume follow-up continue.
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There were no remarkable adverse events following implants of either dose. Repeat implants have been safe to date.
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All patients show improved blood glucose control as reflected by a decrease in their glycated haemoglobin (%HbA1c) level after the implant, apart from Patient #6.
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All blood glucose levels in the seven-point recordings at last follow-up were in the normal range for patients #1, #2, #3, #4, #7. The mean glucose level in all patients is within the range of 5.8 to 8.2 mMol/L. At last follow up, Patient #6 recorded a mean blood glucose of 9.4 mMol/L.
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Two patients, #2 and #7, have both shown an excellent response and do not require exogenously administered insulin:
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Patient #2 is a 37 year old female with a 15-year history of insulin dependent diabetes. This patient has received two implants of 5,000 IEQ/kg and in February 2009 a third implant of 10,000 IEQ/kg. Prior to the first implant this patient required an average daily insulin dose of 22 units/day. This patient’s HbA1c level prior to implant was 8.2% and is currently 7.1%, her current mean blood glucose level is normal at 6.8 mMol/L.
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Patient #7 is a 63 year old male with a 5-year history of insulin dependent diabetes. He received one implant at the dose of 10,000 IEQ/kg in January 2009. Prior to implant this patient required an average daily insulin dose of 37 units/day. This patient’s HbA1c level prior to implant was 8.3% and is currently 4.8%, his current mean blood glucose level is normal at 6.6 mMol/L.
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As previously reported, capsules containing viable cells have been retrieved from second implants and porcine insulin has been detected in blood of patients following glucose tolerance test.
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The body weight of all patients during the study varied by less than 5% of their pre-implant weight.
