ASC COVID-19: ASC Therapy for Patients With Severe Respiratory COVID-19

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04341610
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.3
• Patients Per Site Per Month: 0

Study Details

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
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double-blind placebo-controlledDouble-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
• Anticipated Study Start Date: Apr 20, 2020
• Anticipated Primary Completion Date: Jan 30, 2021
• Anticipated Study Completion Date: Apr 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 [day 7 from randomization]

Secondary Outcome Measures

1. Days of respirator treatment [3 months]

2. Improvement of clinical symptoms including duration of fever and respiratory need [3 months]

3. Mortality [3 months]

4. Marker of Immunological function -CD4+ and CD8+ T cell count [3 months]

5. C-reactive protein and leucocyte [3 months]

6. Cytokine profile [3 months]

7. Glomerular Filtration Rate [3 months]

8. Duration of hospitalization [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JKastrup, Professor MD, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT04341610
• Other Study ID Numbers: EudraCT number: 2020-001330-36
• First Posted: Apr 10, 2020
• Last Update Posted: May 27, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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

Study Results

No Results Posted as of May 27, 2020