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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

Sponsor
Andalusian Network for Design and Translation of Advanced Therapies (Other)
Overall Status
Completed
CT.gov ID
NCT04366323
Collaborator
(none)
26
Enrollment
6
Locations
2
Arms
20.1
Actual Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I / II Clinical Trial, Multicenter, Randomized and Controlled, 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
Actual Study Start Date :
Apr 27, 2020
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Two doses of 80 million adipose-tissue derived mesenchymal stem cells
No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate [12 months]

  2. Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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:

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario de Jerez de la Frontera Jerez de la Frontera Cádiz Spain 11407
2 Hospital Reina Sofía Córdoba Spain 14004
3 Hospital Universitario Virgen de las Nieves Granada Spain 18014
4 Hospital Universitario Virgen Macarena Sevilla Spain 41009
5 Hospital Unversitario Virgen del Rocío Sevilla Spain 41013
6 Hospital Nuestra Señora de Valme Sevilla Spain 41014

Sponsors and Collaborators

  • Andalusian Network for Design and Translation of Advanced Therapies

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andalusian Network for Design and Translation of Advanced Therapies
ClinicalTrials.gov Identifier:
NCT04366323
Other Study ID Numbers:
  • AdiQure/COVID-19
First Posted:
Apr 28, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pneumonia

Study Results

No Results Posted as of Apr 6, 2022