New gene therapy trials open to recruits
28 May 2012
Two UCL-sponsored multi-centre trials of gene therapy for leukaemia have opened to recruitment, after the JRO clinical trials team worked closely with the CIs to overcome the regulatory hurdles faced by advanced therapy trials.
One trial led by Dr Emma Morris has opened at UCLH with further sites due to open at the Royal Free, Birmingham Queen Elizabeth and Bristol Royal Infirmary. A second trial led by Dr Persis Amrolia has opened at Great Ormond Street Hospital and will be extended to UCLH and other sites in the European Union.
The clinical trials team has developed and expanded its specialist expertise over the last 2 years with the creation of a number of key dedicated posts. Since the employment of 2 regulatory managers for advanced therapy trials and a sponsor pharmacist/IMP compliance manager in 2010, a trial of cell therapy in acute myeloid leukaemia has closed and is preparing for publication.
One gene therapy trial for inherited retinal disorders achieved its recruitment target in July 2011 and is currently in follow-up. A cell therapy trial of fracture non-union at the Royal National Orthopaedic Hospital and Bristol Royal Infirmary opened to recruitment in October 2011 and another gene therapy trial in set-up since 2008 is due to open before summer at the Royal Free, UCLH and Birmingham Queen Elizabeth.
There are currently a number of early proposals for advanced therapy trials in haemophilia, leukaemia, lung cancer, fetal medicine, inherited retinal dystrophy and tissue engineered organ transplantation.
This growing expertise at the JRO should benefit researchers looking to set-up new trials of Gene Therapy, Cell Therapy and Tissue Engineered Products. For further information contact the regulatory managers for advanced therapy trials: Michelle Quaye (email@example.com tel 020 7679 6595) or Kim Champion (firstname.lastname@example.org tel: 020 7679 9886/6009)