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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Local Anesthesia will be administered. A Stab wound will be created at the harvest site through which a 3.0 or 2.5 mm cannula will be inserted to suction fat using the "syringe" (i.e. manual) technique. A total of 100 cc of lipoaspirate will be collected by manual draw of the adipose tissue into syringes.
Infusion of the study medication at the rate of 575 mL/HR (500ml of LRD5 plus 75ml of ATCell suspended in LRD5) and continue until all received trial medication has been delivered.
Assessment of the Incidence of Serious Adverse Events (SAEs)
Observed Adverse Events (AE's) in the placebo control group will be compared to observed AE in the experimental treatment, if any, in order to assess safety of the experimental treatment.
Time frame: Upon completion of final post treatment clinical visit of all participants
Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)
Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: One week post administration
Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)
Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: Two weeks post administration
Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)
Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
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Time frame: Three weeks post administration
Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)
Completed by Participant as a part of physician visits at baseline, and once per week following treatment. Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: Four weeks post administration
Assessment of Changes in Exosome/Cytokine/Chemokine Testing
Blood samples will be collected for testing to measure the selected cytokine and chemokines blood panels described below at screening (baseline), at the pre-treatment clinical visit, and the one- and four-week clinical visits following treatment
Time frame: Once per week for four weeks post administration
Assessment of change in completion time -Six-minute walk test (6MWT)
The 6MWT is a self-paced walking test in which the subject is instructed to walk as fast as possible for 6 minutes. The 6WMT will be completed by each participant at the screening, pre-Treatment clinical visit and at the one week and four week post treatment clinical visits.
Time frame: Four weeks post administration
Assessment of Change in Complete blood count with differential (CBC with diff) Laboratory Testing Results
Complete blood count with differential (CBC with diff)Test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline
Time frame: Each week for four weeks post administration
Assessment of Change in Lactate dehydrogenase (LDH) Laboratory Testing Results
Lactate dehydrogenase (LDH) test results are to be assessed in this study are complete blood count with differential (CBC with diff), to identify any significant change in results positive or negative with the change reported as a percentage change from baseline
Time frame: Each week for four weeks post administration
Assessment of Change in Prothrombin time/partial thromboplastin time (PT/PTT Coagulation factors II) Laboratory Testing Results
Prothrombin time/partial thromboplastin time (PT/PTT Coagulation factors II) test results are to be assessed to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.
Time frame: Each week for four weeks post administration
Assessment of Change in Troponin Laboratory Testing Results
Troponin test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.
Time frame: Each week for four weeks post administration
Assessment of Change in D-dimer Laboratory Testing Results
D-dimer test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.
Time frame: Each week for four weeks post administration
Assessment of Change in Fibrinogen (Coagulation factors II) Laboratory Testing Results
Fibrinogen (Coagulation factors II) test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.
Time frame: Each week for four weeks post administration
Assessment of Change in estimated glomerular filtration rate Laboratory Testing Results
estimated glomerular filtration rate (eGFR) test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.
Time frame: Each week for four weeks post administration
Assessment of Change in Urinalyses Laboratory Testing Results
Urinalyses test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.
Time frame: Each week for four weeks post administration
Assessment of Change in Spot creatinine Laboratory Testing Results
Spot creatinine test results are to be assessed in this study to identify any significant change in results positive or negative with the change reported as a percentage change from baseline.
Time frame: Each week for four weeks post administration