ASC Therapy for Patients With Severe Respiratory COVID-19

Respiratory Tract Diseases Clinical Trial

— ASC 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04341610
• Other study ID #: EudraCT number: 2020-001330-36
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: April 20, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Tract Diseases

Intervention

Drug:
• Stem Cell Product
100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline

Locations

Country	Name	City	State
Denmark	2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in clinical critical treatment index		day 7 from randomization
Secondary	Days of respirator treatment		3 months
Secondary	Improvement of clinical symptoms including duration of fever and respiratory need		3 months
Secondary	Mortality		3 months
Secondary	Marker of Immunological function -CD4+ and CD8+ T cell count		3 months
Secondary	C-reactive protein and leucocyte		3 months
Secondary	Cytokine profile		3 months
Secondary	Glomerular Filtration Rate		3 months
Secondary	Duration of hospitalization		3 months