A phase I safety and tolerability study of infusing the autologous progeny of an adult CD34+ subset into patients with type I diabetes mellitus and a successful renal transplant. - Stem cell and diabetes study

Imperial College London0 个研究点目标入组 7 人开始时间: 2006年7月23日最近更新: 2019年11月25日

适应症

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•Male or female patients aged from 16 to 65 years of age
•Patient with Type I diabetes mellitus plus:
•Successful previous kidney transplant.
•Good kidney allograft function /no episodes of rejection
•for at least one year post-transplant
•Not taking steroids as part of standard immuno-suppression
•Has a WHO performance score of less than 2
•Has a life expectancy of at least 3 months
•Ability to give written consent
•Women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients below the age of 16 or above the age of 65 years
•Patients with chronic pancreatitis and poor exocrine pancreatic function
•Pregnant or lactating women
•Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis
•Patients with evidence of HIV or other life threatening infection
•Patients unable to give written consent
•Patients with a history of hypersensitivity to G-CSF
•Patients who have been included in any other clinical trial within the previous month

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