Treatment of Long COVID Utilizing Autologous Stem Cells

The project is described as a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and secondarily to be vigilant for signals of amelioration of symptoms associated with Post-Acute Sequelae of SARS-CoV-2 infection

Inclusion Criteria:Active duty service members: military retirees, DEERS eligible dependents who are Tricare beneficiaries only (Department of Defense (DoD) investigational sites only)Participants ages of 18 years and aboveDocumentation of a positive COVID-19 polymerase chain reaction (PCR) test or strong history of SARS-CoV-2 exposure with positive supportive serologyMale or female or other genderIndividuals with established diagnosis of PASCSubjects with moderate to severe levels of PASC based on synthesis of multiple assessment modalities provided by the multispecialty study team.PASC phenotype to include signs and symptoms of fatigue and low endurance and either Autonomic Disorder or Dyspnea or both.Subjects who are able to comprehend the consent procedure and follow the treatment process.Female participants of childbearing potential and at risk of pregnancy during the study must agree to use 2 highly effective methods of contraception throughout the study and for 112 days after the last study visit.Female participant who are not of childbearing potential (i.e,. must meet at least one (1) of the following criteria): have undergone a hysterectomy and/or bilateral oophorectomy, or ovarian failure .For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a barrier method of contraception (condom) from the start of study therapy until ≥ 90 days after the end of the study and to refrain from sperm donation until ≥ 90 days after the end of the study.Achieved postmenopausal status defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or psychological cause and have a serum follicle stimulating hormone (FSH) level confirming the post-menopausal state.Individuals who are willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures through the end of the final study visit.Individuals with the following Vital Signs:Systolic Blood Pressure of > 100 or < 140 (mmHg)Diastolic Blood Pressure of > 60 or <90 (mmHg)Heart Rate of > 60 or < 100 (bpm) (beats per minute)Temperature of < 38°C (afebrile)Respiratory Rate of > 12 or < 20 (bpm) (breaths per minute)Pulse Ox greater than >95% on room airBMI < 28Exclusion Criteria:5.3.7.4 Exclusion Criteria:Subjects with documented past or current history of severe depression, suicidal ideations or suicidal attempts.Subjects who are unable to comprehend the content of informed consentFemale subjects who are pregnant or who are not willing to practice effective contraception during and for 112 days following the last study visitFemale subjects who are breastfeedingHistory of abnormal brain or spinal MRI for presence of thromboembolic events.Recent traumatic brain injury or other concussive event within 12 months of medical history reviewHistory of abnormal Echocardiogram for cardiac structure or function in the last 10 years.Prior history of postural orthostatic tachycardia syndrome predating diagnosis of SARS-CoV2 infectionUncontrolled hypertension or hyperlipidemiaPrior to COVID diagnosis, the presence of abnormal chest x-ray for any parenchymal disease, or,Active tuberculosis or ongoing treatment for tuberculosis or any acute or chronic infection affecting lungChronic lung disease due to fibrosis or autoimmune inflammation such as sarcoidosis or rheumatoid arthritis, vasculitis or lupusLung cancerAsthmaChronic obstructive pulmonary disease (COPD)EmphysemaDisorders of upper airway, larynx, or trachea that pose potential complications in a state of emergency for airway management due to SAE.Disorders of pleura that affects pulmonary functionsPrior history of connective tissue diseasesHistory of severe hospitalization from COVID-19 or other respiratory infection requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)Pulse oxygenation readings <95% on room air during screening examHistory of pulmonary embolism during lifetimePrior history of deep venous thromboses, stroke or myocardial infarctionAny thrombophilia, including factor V Leiden, protein C deficiency, and protein S deficiencyOngoing pharmaceutical or radiation treatment for infection or malignancyPrior positive test for any of the following without demonstration of resolution: viral Hepatitis B or C (HBV, HCV), Human Immunodeficiency virus -1 or -2 (HIV1 or HIV2), Human T cell leukemia virus -I or -II (HTLV-1 or HTLV-II), West Nile, Zika, Syphilis.Use of any immunosuppressive, immune modulating drugs include calcineurin inhibitors, antimetabolites, alkylating agents, for greater than 14 consecutive days over the last 3 monthsActively listing (or expected listing) for transplant of any organ, other than corneal, bone, skin, ligament or tendon transplant.Be an organ transplant recipient in the past, other than for corneal, bone, skin, ligament or tendon transplant.History of malignant tumor within the past 10 years for breast cancer and 5 years for all other cancers.Individuals allergic to local anestheticsIndividuals with inadequate subcutaneous tissue to allow appropriate lipoaspirate (i.e., fat extraction)Any history of autoimmune illnesses including but not limited to: Multiple sclerosis, Crohn's disease, Myasthenia gravis, Hashimoto's thyroiditis, psoriatic arthritis, Pernicious anemia/atrophic gastritis, Guillain-Barre, Chronic inflammatory demyelinating polyneuropathy, Type 1 diabetes mellitus, Inflammatory bowel disease, Systemic lupus erythematosus, vasculitis, Immune thrombocytopenic purpura, inflammatory muscle disease or Rheumatoid arthritis, Rheumatic fever.Uncontrolled type 2 diabetesAny abnormal test result, in the opinion of the PI and the study team, that may compromise the safety or compliance of the participant or preclude successful completion of the study, or that may compromise the validity of the study.Individuals expecting retirement, military separation, deployment or relocation in the next 12 months.