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SVF for Treating Pulmonary Fibrosis Post COVID-19

NCT06304623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-12

No results posted yet for this study

Summary

General description of the study

This is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF.

Primary objective

The purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19.

Secondary objective

To evaluate the efficacy of the initial treatment with SVF IV.

Conditions

Interventions

BIOLOGICAL

Autologous adipose-derived SVF IV administration

Subjects received an intravenous injection of autologous adipose-derived SVF.

Sponsors & Collaborators

  • Ministerio de Salud de Nicaragua

    collaborator UNKNOWN

  • Wake Forest University

    collaborator OTHER

  • National Autonomous University of Nicaragua

    collaborator OTHER

  • Michael H Carstens

    lead OTHER

Principal Investigators

  • Carlos Lopez, MD · Hospital Escuela Oscar Danilo Rosales, Leon (HEODRA)

  • Yanury Dolmus, MD · Hospital Escuela Cesar Amador Molina, Matagalpa (HECAM)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Nicaragua

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06304623 on ClinicalTrials.gov