Trials / Unknown
UnknownNCT04805086
The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19
Phase I/II MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Up to a third of patients who recovered from SARS coronavirus (SARS-CoV) had a 20% decline in lung function with a long term reduction in exercise capacity and SF-36 health status a year after infection. Similar outcomes are now being reported in COVID-19 patients, with interstitial lung disease (fibrosis) and long term lung function decline being a common feature. Anti-fibrotic monocytes/macrophages are important for the clearance of partially degraded collagen fragments of fibrotic extracellular matrix, in particular fibrillary-type collagen. MON002 is an autologous monocyte product, cultured in vitro prior to intravenous delivery into patients with post-COVID-19 lung fibrosis.
Detailed description
The MONACO Cell Therapy Study is a prospective, non-randomised, open label study phase I/II clinical trial with a key objective of evaluating safety of MON002 in 5 adults who have a clinical diagnosis of interstitial lung disease (pulmonary fibrosis) after recovery from acute COVID-19 infection. The main objectives of this study are to: (1) to determine the safety profile of MON002 by assessing clinical responses in adults with post-COVID-19 pulmonary fibrosis and (2) to assess its impact on reducing disease morbidity/severity in this population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MON002 | Autologous monocytes |
Timeline
- Start date
- 2021-03-08
- Primary completion
- 2022-06-01
- Completion
- 2023-03-05
- First posted
- 2021-03-18
- Last updated
- 2021-03-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04805086. Inclusion in this directory is not an endorsement.