Respiratory Tract Diseases
Conditions
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 for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system. This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death. We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC\_ASCs from adipose tissue. The aim is to assess the impact of CSCC\_ASCs on the activated immune system and clinical efficacy on pulmonary function. The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.
Interventions
100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind placebo-controlled
Intervention model description
Double-blind placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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: 1. Respiratory distress, RR ≥ 30/min; 2. Oxygen saturation ≤ 93% at rest state; 3. 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in clinical critical treatment index | day 7 from randomization |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of clinical symptoms including duration of fever and respiratory need | 3 months |
| Mortality | 3 months |
| Marker of Immunological function -CD4+ and CD8+ T cell count | 3 months |
| Days of respirator treatment | 3 months |
| Cytokine profile | 3 months |
| Glomerular Filtration Rate | 3 months |
| Duration of hospitalization | 3 months |
| C-reactive protein and leucocyte | 3 months |
Countries
Denmark
Outcome results
None listed