Status:
WITHDRAWN
ASC Therapy for Patients With Severe Respiratory COVID-19
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Respiratory Tract Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential ...
Eligibility Criteria
Inclusion
- Patients between 18-80 years
- Confirmed HCoV-19 infection
- Temperature above 38.0o C
- Pulmonary symptoms and signs, at least one of the following before clinical decision for intubation and respirator treatment:
- Respiratory distress, RR ≥ 30/min;
- Oxygen saturation ≤ 93% at rest state;
- Arterial partial pressure of oxygen (PaO2) / Fraction of inspiration O2 (FiO2) ≤ 300mmHg, 1mmHg=0.133kPa
- Pneumonia that is judged by chest radiograph or computed tomography
- In respirator and possible for treatment within the first 24 hours
Exclusion
- Patients that have need for additional immunosuppressive treatment
- Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
- Co-Infection with other infectious agent.
- Females capable of becoming pregnant must have a negative pregnancy test prior to treatment. After inclusion, they must use contraceptives for 2 months following the given stem cell treatment. The pill, spiral, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
- Patients who are participating in other clinical trials.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04341610
Start Date
April 20 2020
End Date
April 30 2021
Last Update
May 27 2020
Active Locations (1)
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1
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, Denmark, 2100