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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

Andalusian Network for Design and Translation of Advanced Therapies

Status and phase

Completed
Phase 2
Phase 1

Conditions

Sars-CoV2

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04366323
AdiQure/COVID-19

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

  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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Experimental
Experimental group
Treatment:
Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Control
No Intervention group

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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