ASC Therapy for Patients With Severe Respiratory COVID-19

NCT04341610 | Withdrawn Phase 1 DMC

• 1 other identifier: EudraCT number: 2020-001330-36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in clinical critical treatment index

  day 7 from randomization

Secondary Outcomes (8)

• Days of respirator treatment

  3 months

• Improvement of clinical symptoms including duration of fever and respiratory need

  3 months

• Mortality

  3 months

• Marker of Immunological function -CD4+ and CD8+ T cell count

  3 months

• C-reactive protein and leucocyte

  3 months

Study Arms (2)

ASC

ACTIVE COMPARATOR

100 million allogeneic adipose-derived mesenchymal stromal cell

Drug: Stem Cell Product

Placebo

PLACEBO COMPARATOR

Saline

Drug: Stem Cell Product

Interventions

Stem Cell Product DRUG

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

ASC; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Respiratory distress, RR ≥ 30/min;
• Oxygen saturation ≤ 93% at rest state;
• 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

You may not qualify if:

• 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.
• Patients who are participating in other clinical trials.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Model Details: Double-blind placebo-controlled

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 20, 2020
• Primary Completion: January 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

DK (1)