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

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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Digital Oximetry

Pulmonary Function Analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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