Status:
WITHDRAWN
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Post COVID-19
Lead Sponsor:
GID BIO, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18-75 years
Phase:
NA
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 continui...
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...
Eligibility Criteria
Inclusion
- Subjects that are ambulatory and previously hospitalized for a confirmed diagnosis of COVID-19 using RT-PCR test
- Male or female subjects between the ages of 18-75
- SpO2 \> 92% on room air
- Subjects with BMI ≥22
- Subjects with Forced Vital Capacity (FVC) ≥ 40% predicted and ≤ 70% predicted
- Subjects with DLCO ≥ 20% predicted and ≤ 70% predicted
- Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study before any study procedures are performed
- Subjects with the ability to speak, read and understand English
- Subjects with the ability to complete follow up as specified in the protocol
Exclusion
- Subjects taking immunosuppressive drugs
- Subjects with history of lung malignancy
- Subjects allergic to lidocaine or epinephrine
- Women that are pregnant or planning to become pregnant during the study
- Women that are lactating
- Women on hormonal contraceptives in the past 30 days
- Women currently on hormone replacement therapy
- Subjects with chronic kidney disease Stage 4 and Stage 5
- Subjects with a history of pulmonary embolism
- Subjects with a history of anti-phospholipid syndrome
- Subjects participating in any other clinical study
- Subjects with history of deep vein thrombosis
- Subjects with history of Cirrhosis with Pugh classification of B or C
- Subjects on hemodialysis
- Subjects with organ dysfunction or predisposed to organ dysfunction (i.e., pre-dialysis \& orthopnea)
- Subjects with a history of prior clotting disorders or thrombotic syndrome
- Subjects with myocardial infarction within the past 2 months
- Subjects with blood pressure \<85/50 mmHg or \>160/100 mmHg or mean arterial pressure \<60 mmHg or \>120 mmHg
- Subjects with a history of drug or alcohol abuse
- Pulse \<50 bpm or \>140 bpm
- Cardiac rhythm showing rapid atrial fibrillation with heart rate \>120 bpm or ventricular tachycardia
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06940765
Start Date
September 1 2021
End Date
May 1 2022
Last Update
April 23 2025
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