Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Post COVID-19

NCT06940765 | Withdrawn FDA Device

• 1 other identifier: GIDC19-2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an early feasibility study to evaluate the safety of a single intravenous injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of continuing respiratory distress after recovery from COVID-19.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Safety- adverse events

  Evaluation of type and frequency of adverse events.

  Baseline to 3 months post treatment

Secondary Outcomes (3)

• Pulmonary Function - SpO2(%)

  Baseline to 3 months post treatment

• Pulmonary Function - Forced Vital Capacity

  Baseline to 3 months post treatment

• Pulmonary Function - Carbon Monoxide diffusing Capacity

  Baseline to 3 months post treatment

Study Arms (1)

Open Label Treatment Arm

EXPERIMENTAL

A single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from COVID-19 for reintroduction to the same patient during a single surgical procedure.

Device: GID SVF-2 Device System

Interventions

GID SVF-2 Device System DEVICE

The GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue.

Open Label Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects that are ambulatory and previously hospitalized for a confirmed diagnosis of COVID-19 using RT-PCR test
• Male or female subjects between the ages of 18-75
• SpO2 \> 92% on room air
• Subjects with BMI ≥22
• Subjects with Forced Vital Capacity (FVC) ≥ 40% predicted and ≤ 70% predicted
• Subjects with DLCO ≥ 20% predicted and ≤ 70% predicted
• Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study before any study procedures are performed
• Subjects with the ability to speak, read and understand English
• Subjects with the ability to complete follow up as specified in the protocol

You may not qualify if:

• Subjects taking immunosuppressive drugs
• Subjects with history of lung malignancy
• Subjects allergic to lidocaine or epinephrine
• Women that are pregnant or planning to become pregnant during the study
• Women that are lactating
• Women on hormonal contraceptives in the past 30 days
• Women currently on hormone replacement therapy
• Subjects with chronic kidney disease Stage 4 and Stage 5
• Subjects with a history of pulmonary embolism
• Subjects with a history of anti-phospholipid syndrome
• Subjects participating in any other clinical study
• Subjects with history of deep vein thrombosis
• Subjects with history of Cirrhosis with Pugh classification of B or C
• Subjects on hemodialysis
• Subjects with organ dysfunction or predisposed to organ dysfunction (i.e., pre-dialysis \& orthopnea)

Sponsors & Collaborators

• GID BIO, Inc.: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• William Cimino, Phd

  GID BIO

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: April 23, 2025
• Study Start: September 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 23, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share