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CompletedNCT04366323Updated Apr 6, 2022

Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19

A Phase 1/2 interventional study of ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS in Sars-CoV2, sponsored by Andalusian Network for Design and Translation of Advanced Therapies. Completed at 6 sites in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by Andalusian Network for Design and Translation of Advanced Therapies · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

Phase I/II clinical trial to evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia

02

Conditions studied

  • Sars-CoV2

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 26 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Andalusian Network for Design and Translation of Advanced Therapies is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18
  2. Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection
  3. Life expectancy > 48 hours.
  4. Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial.

Exclusion criteria

Exclusion Criteria:

  1. Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C).
  2. History of multiple allergies, including allergy to Penicillin or other Blactams.
  3. Pregnant and lactating women.
  4. Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe.
  5. Patients with autoimmune diseases.
  6. Chronic heart failure with ejection fraction less than 30%.
  7. Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Experimental

    Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

  • No intervention
    Control

Interventions

  • DrugALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

    Two doses of 80 million adipose-tissue derived mesenchymal stem cells

06

What researchers measure

Primary outcomes

  1. Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate

    Time frame: 12 months

  2. Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate

    Time frame: 28 days

07

Study locations

6 sites
  • Hospital Universitario de Jerez de la Frontera
    Jerez de la Frontera, Cádiz 11407, Spain
  • Hospital Reina Sofía
    Córdoba, 14004, Spain
  • Hospital Universitario Virgen de las Nieves
    Granada, 18014, Spain
  • Hospital Universitario Virgen Macarena
    Sevilla, 41009, Spain
  • Hospital Unversitario Virgen del Rocío
    Sevilla, 41013, Spain
  • Hospital Nuestra Señora de Valme
    Sevilla, 41014, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04366323
Lead sponsor
Andalusian Network for Design and Translation of Advanced Therapies
Responsible party
Sponsor
First posted
Apr 28, 2020
Start date
Apr 27, 2020
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021
Last update
Apr 6, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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