Macrophage therapy for liver cirrhosis

Phase 1

Completed

• Conditions: iver cirrhosis; Digestive System; Other and unspecified cirrhosis of liver

• Registration Number: ISRCTN10368050
• Lead Sponsor: ACCORD (UK)

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31591593 safety results (added 10/10/2019) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34750149/ (added 10/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-04
• Study Completion: 2021-08-01
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1. Age 17-65
2. Liver cirrhosis
3. Model for End-Stage Liver Disease (MELD) score 10-16
4. Aetiology liver disease: ALRD, NAFLD, PBC, hemochromatosis, alpha 1 anti trypsin deficiency, previous Hep C with SVR

Exclusion Criteria

1. Refusal or inability to give informed consent to participate in the study
2. Other cause of chronic liver disease/cirrhosis not included in listed aetiologies – this is left to the clinical judgement of the investigator based on previous investigations and trial screening
3. Portal hypertensive bleeding; active episode of bleeding requiring hospitalisation in the last 3 months where varices have not been eradicated by banding
4. Ascites unless, in the opinion of the investigator, the ascites is minimal and well controlled with no increase to diuretic therapy in last 3 months
5. Encephalopathy; current or requiring hospitalisation for treatment in last 3 months
6. Hepatocellular carcinoma – uncertain cases to be discussed at local hepatobiliary multidisciplinary meeting, dysplastic or indeterminate nodules to be excluded, regenerative or other nodules to be included at discretion of MDM
7. Previous diagnosis of hepatocellular carcinoma
8. Previous organ transplant or previous recipient of tissue
9. Listed for liver transplantation
10. Any situation that in the Investigators' opinion may interfere with optimal study participation such as alcohol or drug abuse, domicile too distant from study site, potential non-compliance or inability to co-operate
11. Presence of clinically relevant acute illness that in the opinion of the investigator might compromise the participant’s safe participation in the study
12. Presence or history of cancer within past 5 years with exception of adequately treated localised skin carcinoma, in situ cervical cancer or solid malignancy surgically excised in total without recurrence for 5 years
13. Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Phase I: The safety and feasibility of re-infusion of autologous macrophages, measured 14 days after infusion of 3rd patient in each dose escalation group (model 3+3), and the maximum safe dose of infusion<br> Phase II: Liver function (MELD score) at 3 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Markers of liver fibrosis<br> 2. Disease-related quality of life<br> 3. Liver-related clinical events<br> 4. Transplant-free survival<br> Measured at 3 months and 1 year (improvement in markers of fibrosis of the liver, improvement of quality of life, transplant free)<br>