Autologous Adipose-derived Stromal Vascular Fraction for... | NCT06940765

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

NCT06940765

Sponsor

GID BIO, Inc.

Status

Withdrawn

Last Update Posted

Apr 23, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Covid19

Interventions

GID SVF-2 Device System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No study sites established

Expanded Access Info

Start Date

Sep 2021Estimated

Primary Completion Date

May 2022Estimated

Completion Date

May 2022Estimated

First Submitted Date

Aug 19, 2021

First Submission Date that Met QC Criteria

Apr 21, 2025

First Posted Date

Apr 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2025

Last Update Posted Date

Apr 23, 2025Actual

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)
Subjects with a history of prior clotting disorders or thrombotic syndrome
Subjects with myocardial infarction within the past 2 months
Subjects with blood pressure <85/50 mmHg or >160/100 mmHg or mean arterial pressure <60 mmHg or >120 mmHg
Subjects with a history of drug or alcohol abuse
Pulse <50 bpm or >140 bpm
Cardiac rhythm showing rapid atrial fibrillation with heart rate >120 bpm or ventricular tachycardia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections