Covid19
Conditions
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.
Interventions
DEVICEGID SVF-2 Device System
The GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue.
Sponsors
GID BIO, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety- adverse events | Baseline to 3 months post treatment | Evaluation of type and frequency of adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Function - SpO2(%) | Baseline to 3 months post treatment | Changes in the following test: SpO2 level (%): Oxygen saturation Percent of hemoglobin binding sites in arterial blood occupied by oxygen (%sat) |
| Pulmonary Function - Forced Vital Capacity | Baseline to 3 months post treatment | Changes in the following test: Pulmonary Function (Forced Vital Capacity): Lung volume in liters and percent of predicted |
| Pulmonary Function - Carbon Monoxide diffusing Capacity | Baseline to 3 months post treatment | Changes in the following tests: Carbon Monoxide diffusing Capacity (DLCO): ml/min/mm Hg and percent of predicted |
Outcome results
None listed