MAcrophage Therapy for Liver Cirrhosis (MATCH)
Research type
Research Study
Full title
MAcrophage Therapy for Liver Cirrhosis (MATCH)
IRAS ID
184291
Contact name
Stuart Forbes
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2015-000963-15
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Research Summary
3 participants will be recruited for validation of the GMP manufacturing process only and will not receive any macrophages (conducted under previous protocol REC ref 12/SS/0183). Assuming no adverse events, 9 participants will be recruited for the dose escalation protocol (3 participants to receive up to 10^7 macrophage cells, 3 participants up to 10^8 cells, 3 participants up to 10^9 cells). Given the dose escalation phase will be a 3+3 design, a maximum of 18 patients may be required if adverse events are experienced. When the maximum tolerated dose is defined, 56 participants will be randomised to either standard medical care or to receive 3 infusions of autologous monocyte-derived macrophages a month apart.
Participants will be referred from their local healthcare professional.
The trial is funded by the Medical Research Council
Summary of Results
There are no licensed antifibrotic or pro-regenerative pharmacotherapies for patients with end-stage liver disease and liver transplantation is constrained by an organ supply-demand mismatch. In the phase 1 study we showed good safety and feasibility of peripheral infusion of ex vivo-matured autologous monocyte-derived macrophages in a first-in-human study.
In the phase 2 study, we examined the safety and effect of autologous macrophage therapy in adult patients with compensated cirrhosis in a multicentre, open-label, parallel-group, Phase 2, randomised controlled trial.
There was no statistically significant difference in the baseline to 90-day change in MELD score (a liver cirrhosis severity measure) between patients (n=23) allocated to a single infusion of macrophages compared with patients (n=24) who received standard medical care. The macrophage therapy again had a good safety profile in the phase 2 study.
Regarding clinical events, 5 participants in the control group had a total of 10 serious adverse events (three of which were defined as liver-related events) after one year of follow-up. In the macrophage treatment group, one participant had one serious adverse event and this was non-liver-related. There were two deaths in the control group and none in the macrophage treatment group. The results of this study support further clinical development of macrophage cell therapy in end-stage liver disease.REC name
Scotland B REC
REC reference
15/SS/0121
Date of REC Opinion
19 Jan 2016
REC opinion
Further Information Favourable Opinion