Collaborative work between the MW-ATTC and Cardiff and Vale University Health Board (C&V UHB) has progressed with earnest during 2019 regarding the Rexgenero study (REX-001-004 and REX-001-005).
The REX-001-004/005 study is one of the first exemplar products in the field of advanced therapies to emerge from the MW-ATTC network. The study is looking at the efficacy and safety of intra-arterial administration of REX-001 to those patients with critical limb ischaemia and diabetes in treating ischaemic rest pain (Rutherford Category 4), or treating ischaemic ulceration (Category 5)]. The advanced therapy medicinal product is a cell suspension of autologous bone marrow derived white blood cells (BM-WBCs) composed of several mature cell types as well as progenitor cells.
Full endorsement and communication by Mr Len Richards, Chief Executive at Cardiff and Vale UHB has demonstrated the support and commitment from staff to the effective delivery of the Rexgenero study at C&V UHB site. Local discussions with lead R&D personnel and key health professionals, led by Mr Ian Williams (Principal Investigator), have attributed to each successful phase of the study set-up.
Mr Ian Williams, Consultant vascular surgeon and Principal Investigator said:
“This is an exciting study to examine the effects of injecting patients own cells into the artery of the leg and see if this aids healing of ulcers which is not deemed suitable for radiological techniques or bypass surgery. This also ultimately may reduce the need for extensive wound debridement or even amputation”
A Pre-Site Initiation Visit (Pre-SIV) was held on 21st March 2019 allowing worthwhile advanced discussion between Sponsor and site personnel around the detail of the protocol, local logistics, roles and responsibilities, as well as identifying any potential challenges which could be encountered during any stage of the study.
Subsequently a Site Initiation Visit occurred on 18th April 2019 with contributions from all site study team personnel. Continuous support and assistance from Syneos Health Limited, CRO (Contract Research Organisation) through every phase of the study set-up has provided assurances around robustness and the safe and effective delivery of the study.
Cardiff and Vale UHB site has now been open to recruitment for the REX-001-004/005 study as of 5th June 2019. Mock-run sessions have been incorporated into the schedule and performed to assess local processes, timeliness and logistics. Lessons have been learnt in readiness for active participant recruitment and enrolment. It is anticipated that screening and treatment of participants will occur throughout the forthcoming months as concerted efforts by the PI and study team continue regarding patient pre-screening activities.