ASC Therapy for Patients With Severe Respiratory COVID-19 (ASC COVID-19)

Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy for Treating Patients With Severe Respiratory COVID-19. A Danish, Double-blind, Randomized Placebo-controlled Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Respiratory Tract Diseases
• Intervention / Treatment: Drug: Stem Cell Product

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • 2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline	Drug: Stem Cell Product; 100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline
Active Comparator: ASC; 100 million allogeneic adipose-derived mesenchymal stromal cell	Drug: Stem Cell Product; 100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in clinical critical treatment index	day 7 from randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	3 months
Days of respirator treatment	3 months
Improvement of clinical symptoms including duration of fever and respiratory need	3 months
Marker of Immunological function -CD4+ and CD8+ T cell count	3 months
C-reactive protein and leucocyte	3 months
Cytokine profile	3 months
Glomerular Filtration Rate	3 months
Duration of hospitalization	3 months

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2020
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases
• Other Study ID Numbers: EudraCT number: 2020-001330-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No