search
Back to results

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

Primary Purpose

Sars-CoV2

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Sponsored by
Andalusian Network for Design and Translation of Advanced Therapies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sars-CoV2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario de Jerez de la Frontera
  • Hospital Reina Sofía
  • Hospital Universitario Virgen de las Nieves
  • Hospital Universitario Virgen Macarena
  • Hospital Unversitario Virgen del Rocío
  • Hospital Nuestra Señora de Valme

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 22, 2020
Last Updated
April 5, 2022
Sponsor
Andalusian Network for Design and Translation of Advanced Therapies
search

1. Study Identification

Unique Protocol Identification Number
NCT04366323
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andalusian Network for Design and Translation of Advanced Therapies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Intervention Description
Two doses of 80 million adipose-tissue derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Time Frame
12 months
Title
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection Life expectancy > 48 hours. Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial. Exclusion Criteria: Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C). History of multiple allergies, including allergy to Penicillin or other Blactams. Pregnant and lactating women. Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe. Patients with autoimmune diseases. Chronic heart failure with ejection fraction less than 30%. Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.
Facility Information:
Facility Name
Hospital Universitario de Jerez de la Frontera
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Unversitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs