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

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ClinicalTrials.gov Identifier: NCT04341610
Recruitment Status : Withdrawn (Not approved by ethical committee)
First Posted : April 10, 2020
Last Update Posted : May 27, 2020
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE April 7, 2020
First Posted Date  ICMJE April 10, 2020
Last Update Posted Date May 27, 2020
Estimated Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
Changes in clinical critical treatment index [ Time Frame: day 7 from randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Days of respirator treatment [ Time Frame: 3 months ]
  • Improvement of clinical symptoms including duration of fever and respiratory need [ Time Frame: 3 months ]
  • Mortality [ Time Frame: 3 months ]
  • Marker of Immunological function -CD4+ and CD8+ T cell count [ Time Frame: 3 months ]
  • C-reactive protein and leucocyte [ Time Frame: 3 months ]
  • Cytokine profile [ Time Frame: 3 months ]
  • Glomerular Filtration Rate [ Time Frame: 3 months ]
  • Duration of hospitalization [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE ASC Therapy for Patients With Severe Respiratory COVID-19
Official Title  ICMJE Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy for Treating Patients With Severe Respiratory COVID-19. A Danish, Double-blind, Randomized Placebo-controlled Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Respiratory Tract Diseases
Intervention  ICMJE Drug: Stem Cell Product
100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline
Study Arms  ICMJE
  • Active Comparator: ASC
    100 million allogeneic adipose-derived mesenchymal stromal cell
    Intervention: Drug: Stem Cell Product
  • Placebo Comparator: Placebo
    Intervention: Drug: Stem Cell Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 25, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04341610
Other Study ID Numbers  ICMJE EudraCT number: 2020-001330-36
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party JKastrup, Rigshospitalet, Denmark
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rigshospitalet, Denmark
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP