ASC Therapy for Patients With Severe Respiratory COVID-19

NCT ID: NCT04341610

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2021-04-30

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.

Conditions

Respiratory Tract Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ASC

100 million allogeneic adipose-derived mesenchymal stromal cell

Group Type: ACTIVE_COMPARATOR

Stem Cell Product

Intervention Type: DRUG

100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline

Placebo

Saline

Group Type: PLACEBO_COMPARATOR

Stem Cell Product

Intervention Type: DRUG

100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline

Interventions

Stem Cell Product

100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

JKastrup

Professor MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

EudraCT number: 2020-001330-36

Identifier Type: -

Identifier Source: org_study_id