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Cell Therapy

cSVF Therapy for Post-COVID Lung Damage (GARM-COVID19 Trial)

Q: What criteria have been established for eligibility in this medical experiment?

To enroll in this clinical trial, individuals must be infected with viral pneumonia and between 18-90 years old. This research program is seeking a total of 10 volunteers.

Q: Is the elderly population being incorporated in this research endeavor?

Individuals who are 18 years or older, but under 90, may be eligible for this medical research.

Q: Is this investigation still open to recruitment?

As per data hosted on clinicaltrials.gov, this particular medical trial is not actively searching for participants, with the last update taking place on March 4th 2022 and an original posting date of March 25th 2020. Although recruitment has closed for this study, there are 1,368 other studies recruiting patients at present.

Phase < 1

Waitlist Available

Research Sponsored by Black Tie Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Awards & highlights

GARM-COVID19 Trial Summary

This trial is a study to test a possible treatment for people who have lung damage from the COVID-19 virus. The treatment involves taking cells from the patient's own body and injecting them into the patient's bloodstream. The goal is to see if this can help improve the function of the lungs.

Who is the study for?

This trial is for people who had COVID-19 and now have lasting lung damage. They must have a confirmed history of COVID-19 with lung involvement, no current virus detected, and be able to give informed consent. They should also agree to lung scans before, at 3 months, and at 6 months post-treatment.Check my eligibility

What is being tested?

The study tests the use of a patient's own stromal vascular fraction (cSVF) cells given through an IV to see if they can reduce inflammation and repair damaged lung tissue. This Phase 0 trial is the first time this treatment is being tried in humans.See study design

What are the potential side effects?

Since this is a novel treatment, specific side effects are not yet known but may include typical risks associated with IV treatments such as infection risk at the injection site or allergic reactions to components used during cell processing.

GARM-COVID19 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Digital Oximetry

Pulmonary Function Analysis

GARM-COVID19 Trial Design

5Treatment groups

Experimental Treatment

Group I: Sterile Normal SalineExperimental Treatment2 Interventions

250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV

Group II: LipoaspirationExperimental Treatment1 Intervention

Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue

Group III: Liberase TMExperimental Treatment2 Interventions

Use of sterile Liberase TM enzyme to allow cSVF separation and isolation

Group IV: Isolation & Concentration of cSVFExperimental Treatment2 Interventions

Isolation & Concentration of cellular stromal vascular fraction (cSVF) using Healeon Centricyte 1000 Centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols

Group V: Delivery cSVF via IntravenousExperimental Treatment2 Interventions

cSVF from Arm 2 is suspended in a 250 cc of sterile Normal Saline IV solution and deployed though 150 micron in-line filtration and intravenous route over 30-60 minute timeframe

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Robert W. Alexander, MDUNKNOWN

3 Previous Clinical Trials

210 Total Patients Enrolled

Black Tie Medical, Inc.Lead Sponsor

1 Previous Clinical Trials

100 Total Patients Enrolled

Robert W Alexander, MDStudy ChairGlobal Alliance Regenerative Medicine

6 Previous Clinical Trials

860 Total Patients Enrolled

Media Library

cSVF (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04326036 — Phase < 1

Pulmonary Alveolar Proteinosis Research Study Groups: Isolation & Concentration of cSVF, Delivery cSVF via Intravenous, Liberase TM, Lipoaspiration, Sterile Normal Saline

Pulmonary Alveolar Proteinosis Clinical Trial 2023: cSVF Highlights & Side Effects. Trial Name: NCT04326036 — Phase < 1

cSVF (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04326036 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria have been established for eligibility in this medical experiment?

"To enroll in this clinical trial, individuals must be infected with viral pneumonia and between 18-90 years old. This research program is seeking a total of 10 volunteers."

Answered by AI

Is the elderly population being incorporated in this research endeavor?

"Individuals who are 18 years or older, but under 90, may be eligible for this medical research."

Answered by AI

Is this investigation still open to recruitment?

"As per data hosted on clinicaltrials.gov, this particular medical trial is not actively searching for participants, with the last update taking place on March 4th 2022 and an original posting date of March 25th 2020. Although recruitment has closed for this study, there are 1,368 other studies recruiting patients at present."

Answered by AI