Status and phase
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Treatments
About
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
Full description
The proposed study is a randomized single-center, double-blinded, placebo controlled standard of care plus study. Each participant will continue to receive standard of care treatment for their current diagnosis and be afforded the opportunity to add any additional care as needed that may include care for behavioral health concerns. In the proposed study, safety of a single administration of expanded autologous lines at a total dose exposure of 150 million cells ("ATCell™") will be assessed. Each ATCell™ cell batch will be derived from ex vivo expanded stromal vascular fraction (SVF) of a participant's own adipose tissue. SVF is collected by liposuction and expanded. Briefly, ATCell suspended in Lactated Ringer's with 5% dextrose solution, or a placebo of Lactated Ringers 5% dextrose solution will be administered once to each participant. Safety will be evaluated through clinical assessments and laboratory test results comparing treatment cohort participant's baseline assessments and laboratory test results. Following completion of follow up period as defined in the schedule of events, the study will be unblinded, the results reviewed by the Institutional Review Board (IRB) and Human Research Protection Program (HRPP). Once safety has been reviewed by IRB/ HRPP, the study will be unblinded and participants that received the placebo treatment will be offered the opportunity to crossover and receive 150 million cell ATCell™ autologous treatment with the same monitoring and clinical support afforded to the first treatment cohort.
Enrollment
Sex
Ages
Volunteers
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 above
Documentation of a positive COVID-19 polymerase chain reaction (PCR) test or strong history of SARS-CoV-2 exposure with positive supportive serology
Male or female or other gender
Individuals with established diagnosis of PASC
Subjects 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:
Exclusion 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 consent
Female subjects who are pregnant or who are not willing to practice effective contraception during and for 112 days following the last study visit
Female subjects who are breastfeeding
History 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 review
History 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 infection
Uncontrolled hypertension or hyperlipidemia
Prior to COVID diagnosis, the presence of abnormal chest x-ray for any parenchymal disease, or,
Prior history of connective tissue diseases
History 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 exam
History of pulmonary embolism during lifetime
Prior history of deep venous thromboses, stroke or myocardial infarction
Any thrombophilia, including factor V Leiden, protein C deficiency, and protein S deficiency
Ongoing pharmaceutical or radiation treatment for infection or malignancy
Prior 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 months
Actively 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 anesthetics
Individuals 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 diabetes
Any 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.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
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Central trial contact
Anthony Dudzinski
Data sourced from clinicaltrials.gov
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