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NCT04341610: ASC COVID-19

ASC Therapy for Patients With Severe Respiratory COVID-19

Withdrawn Phase 1, PHASE2 Last updated 27 May 2020
What this trial tests

Phase 1, PHASE2 trial testing Stem Cell Product in Respiratory Tract Diseases. Withdrawn.

Timeline
20 April 2020
Primary endpoint
30 January 2021
30 April 2021

Quick facts

Lead sponsorRigshospitalet, Denmark
PhasePhase 1, PHASE2
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Start date20 April 2020
Primary completion30 January 2021
Estimated completion30 April 2021
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 18 to 80, any sex, with Respiratory Tract Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mesenchymal stem cells and exosome therapy for COVID-19: current status and future perspective.
    Gupta A, Kashte S, Gupta M, Rodriguez HC, et al · · 2020 · cited 55× · PMID 32780299 · DOI 10.1007/s13577-020-00407-w
  2. The role of mesenchymal stromal cells in immune modulation of COVID-19: focus on cytokine storm.
    Kavianpour M, Saleh M, Verdi J. · · 2020 · cited 47× · PMID 32948252 · DOI 10.1186/s13287-020-01849-7
  3. Mesenchymal stem cell therapies for COVID-19: Current status and mechanism of action.
    Sadeghi S, Soudi S, Shafiee A, Hashemi SM. · · 2020 · cited 43× · PMID 32979360 · DOI 10.1016/j.lfs.2020.118493
  4. Mesenchymal stem cell immunomodulation: In pursuit of controlling COVID-19 related cytokine storm.
    Song N, Wakimoto H, Rossignoli F, Bhere D, et al · · 2021 · cited 39× · PMID 33586320 · DOI 10.1002/stem.3354
  5. Reducing mortality and morbidity in patients with severe COVID-19 disease by advancing ongoing trials of Mesenchymal Stromal (stem) Cell (MSC) therapy - Achieving global consensus and visibility for cellular host-directed therapies.
    Zumla A, Wang FS, Ippolito G, Petrosillo N, et al · · 2020 · cited 37× · PMID 32425638 · DOI 10.1016/j.ijid.2020.05.040
  6. Mesenchymal stem cell-based treatments for COVID-19: status and future perspectives for clinical applications.
    Chen L, Qu J, Kalyani FS, Zhang Q, et al · · 2022 · cited 31× · PMID 35187617 · DOI 10.1007/s00018-021-04096-y
  7. State of the Art Review of Cell Therapy in the Treatment of Lung Disease, and the Potential for Aerosol Delivery.
    Brave H, MacLoughlin R. · · 2020 · cited 31× · PMID 32899381 · DOI 10.3390/ijms21176435
  8. Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines).
    Slimano F, Baudouin A, Zerbit J, Toulemonde-Deldicque A, et al · · 2020 · cited 29× · PMID 32623296 · DOI 10.1016/j.ctrv.2020.102063

Verify or expand the search:

Other trials of Stem Cell Product

Trials testing the same drug.

Other recruiting trials for Respiratory Tract Diseases

Currently open trials in the same condition.

Other Rigshospitalet, Denmark trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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