Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Post COVID-19
NCT ID: NCT06940765
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2021-09-30
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
NCT00992147
The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration
NCT03189628
Autologous Fat Transfer for Scar Prevention and Remodeling
NCT01119326
Autologous Point-of-Care Adipose Therapy: Recent Injury
NCT06857448
Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
NCT02336997
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Open Label Treatment Arm
A single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from COVID-19 for reintroduction to the same patient during a single surgical procedure.
GID 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GID 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GID BIO, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William Cimino, Phd
Role: STUDY_CHAIR
GID BIO
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GIDC19-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.