A FIH Novel Somatic Cell Therapy for COVID-19- AmnioPul-02
Research type
Research Study
Full title
A First-In-Human Phase 1b, Open-Label Trial to Evaluate Safety and Tolerability of a Novel Somatic Cell Therapy - AmnioPul-02 - in Subjects with Confirmed COVID-19
IRAS ID
1004634
Contact name
Lars Larsson
Contact email
Sponsor organisation
Amniotics AB
Eudract number
2020-004171-40
Research summary
There are few treatments for COVID-19 approved or under consideration for Marketing Authorisation. Most are limited to supportive care. The mortality rate for critically ill patients with acute respiratory distress syndrome (ARDS) is high and a large proportion of recovered patients go on to develop pulmonary fibrosis (damage to the lungs, scarring, making it difficult to breathe). One of the pathological features of ARDS is dysregulation of inflammation, where the immune system becomes over stimulated and this leads to lung injury.
AmnioPul-02 was developed to meet this unmet medical need. This is a Phase 1b First In Human (FIH) study, for patients with moderate to severe illness due to COVID-19 infection.
AmnioPul-02 is an advanced therapy investigational medicinal product (ATIMP), a stem cell therapy. Stem cells have been obtained from amniotic fluid (TAF) donations at planned caesarean sections. Using antibodies, the cells in the TAF which express proteins consistent with those found on lung Mesenchymal Stem Cells (MSC) have been extracted. The selected lung-MSC are then amplified in a laboratory to produce a stock from which the final medicinal product is produced.
AmnioPul-02 is expected to downregulate the immune response and have anti-fibrotic capabilities, as well as aid in recovery and regeneration of the lungs. Immune modulating properties of AmnioPul-02 have been shown using in-vitro (laboratory) tests on immune cells in a dish, and in in vivo (inside a body) using animal studies. No Clinical studies in humans have been conducted yet.
The study will consist of an up to 3 day screening period, followed by dosing on Day 1, and including 3 weeks of follow-up period up to Day 22. Bimonthly follow-up calls (every 60 days±10 days) (including assessment of adverse events related to the ATIMP, Fatigue Assessment Scale, and overall survival status) will start at Month 2 (Day 60±10 days) post dose up to 1 year (Day 360±10 days) post dose.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0001
Date of REC Opinion
4 Apr 2022
REC opinion
Further Information Favourable Opinion