BALANCE WP 6: Preparation clinical trial (M9-M31) (AMC, HepArt & UEDIN) Objectives Objective: To obtain regulatory approval for the planned phase I/IIa.

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Presentation transcript:

BALANCE WP 6: Preparation clinical trial (M9-M31) (AMC, HepArt & UEDIN) Objectives Objective: To obtain regulatory approval for the planned phase I/IIa study and to make practical preparations for clinical testing to prepare all necessary organisational arrangements 6.2. to complete study protocol, investigator brochure and acquire approval from regulatory bodies 6.3. to instruct and train clinical personnel

BALANCE WP6: Description of work Designing investigator database (website) - Notifying the study (CCMO & MHRA) - Trial insurance aspects - Contracts for finances Setting up: clinical protocol, IMPD, investigators brochure, CRF’s, monitoring forms, informed consent. - Getting approval of CCMO and MHRA 6.3- instruction and training ICU personnel

BALANCE WP6: Deliverables & Milestone Deliverables - Report on organisational arrangements (M31) - Regulatory approval (M31) - Instruction personnel finished (M28). MILESTONE Approval of clinical trial (M31)

BALANCE WP 7:Clinical trial (AMC, PharmaCell & UEDIN) Objectives To show safety and feasibility of HepaRG-BAL in 10 ALF patients 7.1. To produce and transport the bioreactor cultures to hospital locations 7.2. To determine safety & feasibility of BAL treatment in ALF patients 7.3. To determine the effect of patient treatment on HepaRG functionality

BALANCE WP7: Description of work 7.1. Supplying bioreactor cultures (PhC) - 20 fully functional and quality controlled HepaRG-BALS - Shipment, using transport system of WP3 (M28) 7.2. Treatment of patients and data analysis (UEDIN & AMC) - Treatment according to clinical protocol - Data analysis and reporting results and adverse events to monitoring committee 7.3. Post treatment analysis of bioreactor cultures: - Study of possible toxic effect of ALF plasma on functionality and secretome

BALANCE WP7: Deliverables & Milestone Deliverables - Report on supply of bioreactor cultures to hospitals. Certificate of quality analysis and delivery report (PhC) - Report on safety, efficacy and feasibility of HepaRG BAL treatment of ALF patients (UEDIN & AMC) - Report on the effect of ALF plasma on HepaRG BAL (UEDIN & AMC). MILESTONE Safety and feasibility of HepaRG BAL treatment of ALF patients (M36)