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

• ClinicalTrials.gov Identifier: NCT04341610
• Recruitment Status: Withdrawn
• First Posted: April 10, 2020
• Last Update Posted: May 27, 2020
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): JKastrup, Rigshospitalet, Denmark

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Tract Diseases	Drug: Stem Cell Product	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double-blind placebo-controlled
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blind placebo-controlled
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: April 20, 2020
• Estimated Primary Completion Date: January 30, 2021
• Estimated Study Completion Date: April 30, 2021

Arms and Interventions

Arm	Intervention/treatment
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
Placebo Comparator: Placebo; Saline	Drug: Stem Cell Product; 100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline

Outcome Measures

Primary Outcome Measures :

1. Changes in clinical critical treatment index [ Time Frame: day 7 from randomization ]

Secondary Outcome Measures :

1. Days of respirator treatment [ Time Frame: 3 months ]
2. Improvement of clinical symptoms including duration of fever and respiratory need [ Time Frame: 3 months ]
3. Mortality [ Time Frame: 3 months ]
4. Marker of Immunological function -CD4+ and CD8+ T cell count [ Time Frame: 3 months ]
5. C-reactive protein and leucocyte [ Time Frame: 3 months ]
6. Cytokine profile [ Time Frame: 3 months ]
7. Glomerular Filtration Rate [ Time Frame: 3 months ]
8. Duration of hospitalization [ Time Frame: 3 months ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Denmark

2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet

Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

More Information

• Responsible Party: JKastrup, Professor MD, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT04341610
• Other Study ID Numbers: EudraCT number: 2020-001330-36
• First Posted: April 10, 2020
• Last Update Posted: May 27, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Respiratory Tract Diseases