Status:
UNKNOWN
A Study to Collect Bone Marrow for Process Development and Production of BM-MSC to Treat Severe COVID19 Pneumonitis
Lead Sponsor:
CCTU- Cancer Theme
Collaborating Sponsors:
Cambridge Cellular Therapies Laboratory
The Evelyn Trust
Conditions:
Healthy Volunteers for Bone Marrow Donation
Eligibility:
All Genders
18-40 years
Brief Summary
The COVID-19 pandemic, commonly referred to as "coronavirus", first began in the city of Wuhan, China in December 2019. This virus has since spread globally, with infections reported in nearly every c...
Eligibility Criteria
Inclusion
- Have given written informed consent to participate
- Be aged between 18 and 40 years old
- Have Eastern Cooperative Oncology Group (ECOG) performance status 0
- Be negative for mandatory infectious disease markers (IDM) as per World Marrow Donor Association (WMDA) guidelines
- Present a negative SARS-CoV2 screen
- Show absence of clinical symptoms of COVID-19 (Not have been in known COVID-19 contact within the previous 14 days, Adherence to national social distancing guidelines for 14 days)
- Have a BMI \<35kg/m\^2
- Women of childbearing potential need a negative pregnancy test (urine or blood) within 7 days prior to the marrow collection
Exclusion
- Any major disease which would represent a contraindication to bone marrow donation based on WMDA guidelines
- Presence of any previous or active malignancy (other than non-melanoma skin cancer)
- Any other concurrent severe and/or uncontrolled medical condition
- Women who are pregnant or breast-feeding
- Any acute or chronic back complaint
- Presence of anaesthetic risk factors
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04397471
Start Date
May 1 2020
End Date
December 1 2021
Last Update
May 21 2020
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ