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

Adipose-Derived Stromal Vascular Fraction Cell Therapy to Treat Post COVID-19 Respiratory Distress - An Early Feasibility Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Device: GID SVF-2 Device System

Detailed Description

The GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of continuing respiratory distress after recovery from COVID-19.

The primary objective of this study is to evaluate the safety of a single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from initial COVID-19 infection.

The secondary objective is preliminary assessment of feasibility of a single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from COVID-19.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects taking immunosuppressive drugs
2. Subjects with history of lung malignancy
3. Subjects allergic to lidocaine or epinephrine
4. Women that are pregnant or planning to become pregnant during the study
5. Women that are lactating
6. Women on hormonal contraceptives in the past 30 days
7. Women currently on hormone replacement therapy
8. Subjects with chronic kidney disease Stage 4 and Stage 5
9. Subjects with a history of pulmonary embolism
10. Subjects with a history of anti-phospholipid syndrome
11. Subjects participating in any other clinical study
12. Subjects with history of deep vein thrombosis
13. Subjects with history of Cirrhosis with Pugh classification of B or C
14. Subjects on hemodialysis
15. Subjects with organ dysfunction or predisposed to organ dysfunction (i.e., pre-dialysis & orthopnea)
16. Subjects with a history of prior clotting disorders or thrombotic syndrome
17. Subjects with myocardial infarction within the past 2 months
18. Subjects with blood pressure <85/50 mmHg or >160/100 mmHg or mean arterial pressure <60 mmHg or >120 mmHg
19. Subjects with a history of drug or alcohol abuse
20. Pulse <50 bpm or >140 bpm
21. Cardiac rhythm showing rapid atrial fibrillation with heart rate >120 bpm or ventricular tachycardia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label Treatment Arm; 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; The GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety- adverse events	Evaluation of type and frequency of adverse events.	Baseline to 3 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Function - SpO2(%)	Changes in the following test: SpO2 level (%): Oxygen saturation Percent of hemoglobin binding sites in arterial blood occupied by oxygen (%sat)	Baseline to 3 months post treatment
Pulmonary Function - Forced Vital Capacity	Changes in the following test: Pulmonary Function (Forced Vital Capacity): Lung volume in liters and percent of predicted	Baseline to 3 months post treatment
Pulmonary Function - Carbon Monoxide diffusing Capacity	Changes in the following tests: Carbon Monoxide diffusing Capacity (DLCO): ml/min/mm Hg and percent of predicted	Baseline to 3 months post treatment

Collaborators and Investigators

• Sponsor: GID BIO, Inc.
• Investigators: Study Chair: William Cimino, PhD, GID BIO

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2021
• Primary Completion (Estimated): May 1, 2022
• Study Completion (Estimated): May 1, 2022

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: GIDC19-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No