Covid19NCT06940765

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

A study testing GID SVF-2 Device System in people with Covid19, run by GID BIO, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: GID SVF-2 Device System
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Sep 2021to May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

About this study

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

Read the 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.

Conditions: Covid19
Being tested: GID SVF-2 Device System
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06940765
Study group	Role	What they receive
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. Receives: Device: GID SVF-2 Device System

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety- adverse events
Evaluation of type and frequency of adverse events.
Measured: Baseline to 3 months post treatment

Secondary outcomes (3)

Pulmonary Function - SpO2(%)
Changes in the following test:
SpO2 level (%): Oxygen saturation Percent of hemoglobin binding sites in arterial blood occupied by oxygen (%sat)
Measured: 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
Measured: 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
Measured: Baseline to 3 months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2021May 2022

First posted23 Apr 2025
Study startSep 2021 (estimated)
Primary completionMay 2022 (estimated)
Study completionMay 2022 (estimated)

Why it stopped: No study sites established

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06940765
Sponsor's protocol ID: GIDC19-2
Status last verified: Mar 2025
First submitted: 19 Aug 2021
Last updated: 23 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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Home-Based Exercise Tele-Rehabilitation After COVID-19
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A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adipose-Derived Stromal Vascular Fraction Cell Therapy to Treat Post COVID-19 Respiratory Distress - An Early Feasibility Study
ClinicalTrials.gov ID: NCT06940765
Acronym / sponsor ID: GIDC19-2
Conditions: Covid19
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No study sites established
Enrolment: 0 participants (actual)
Lead sponsor: GID BIO, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2021 (estimated)
Primary completion: May 2022 (estimated)
Study completion: May 2022 (estimated)
First posted: 23 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open Label Treatment Arm	Experimental	Device: GID SVF-2 Device SystemA 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GID SVF-2 Device SystemThe GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue.	Device	Open Label Treatment Arm

Primary outcome

Safety- adverse events
Time frame: Baseline to 3 months post treatment
Evaluation of type and frequency of adverse events.

3 secondary outcomes

Pulmonary Function - SpO2(%)
Time frame: Baseline to 3 months post treatment
Pulmonary Function - Forced Vital Capacity
Time frame: Baseline to 3 months post treatment
Pulmonary Function - Carbon Monoxide diffusing Capacity
Time frame: Baseline to 3 months post treatment

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
Individual participant dataSharing planned: No

Related trials for Covid19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Cimino, Phd study chair

GID BIO

Questions about this trial

What is this clinical trial studying?

A study testing GID SVF-2 Device System in people with Covid19, run by GID BIO, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety- adverse events (time frame: Baseline to 3 months post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06940765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.