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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue.
Safety- adverse events
Evaluation of type and frequency of adverse events.
Time frame: Baseline to 3 months post treatment
Pulmonary Function - SpO2(%)
Changes in the following test: SpO2 level (%): Oxygen saturation Percent of hemoglobin binding sites in arterial blood occupied by oxygen (%sat)
Time frame: 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
Time frame: 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
Time frame: Baseline to 3 months post treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.