Clinical trial NCT04341610: ASC Therapy for Patients With Severe Respiratory COVID-19
Official title: Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy for Treating Patients With Severe Respiratory COVID-19. A Danish, Double-blind, Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Respiratory Tract Diseases
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind placebo-controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in clinical critical treatment index
timeFrame: day 7 from randomization
Secondary outcomes:
measure: Days of respirator treatment
timeFrame: 3 months
measure: Improvement of clinical symptoms including duration of fever and respiratory need
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
measure: Marker of Immunological function -CD4+ and CD8+ T cell count
timeFrame: 3 months
measure: C-reactive protein and leucocyte
timeFrame: 3 months
measure: Cytokine profile
timeFrame: 3 months
measure: Glomerular Filtration Rate
timeFrame: 3 months
measure: Duration of hospitalization
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: 2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Study officials:
References: