Clinical trial NCT06940765: Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Post COVID-19
Official title: Adipose-Derived Stromal Vascular Fraction Cell Therapy to Treat Post COVID-19 Respiratory Distress - An Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Covid19
Lead sponsor: GID BIO, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety- adverse events
timeFrame: Baseline to 3 months post treatment
Secondary outcomes:
measure: Pulmonary Function - SpO2(%)
timeFrame: Baseline to 3 months post treatment
measure: Pulmonary Function - Forced Vital Capacity
timeFrame: Baseline to 3 months post treatment
measure: Pulmonary Function - Carbon Monoxide diffusing Capacity
timeFrame: Baseline to 3 months post treatment
Other outcomes:
Locations:
Study officials:
affiliation: GID BIO
name: William Cimino, Phd
role: STUDY_CHAIR
References: