Long COVID
Conditions
Keywords
Long COVID, Post Acute Sequelae
Brief summary
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
Detailed 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.
Interventions
PROCEDUREAdipose Tissue Harvest
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.
BIOLOGICALATCell
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.
Sponsors
American CryoStem Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
To ensure proper Randomization, the Sponsor has elected to use the NIH National Cancer Institute Clinical Trial Randomization tool
Intervention model description
The proposed study is a randomized single-center, double-blinded, placebo controlled standard of care plus study. Once safety has been certified 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Active duty service members: military retirees, DEERS eligible dependents who are Tricare beneficiaries only (Department of Defense (DoD) investigational sites only) 2. Participants ages of 18 years and above 3. Documentation of a positive COVID-19 polymerase chain reaction (PCR) test or strong history of SARS-CoV-2 exposure with positive supportive serology 4. Male or female or other gender 5. Individuals with established diagnosis of PASC 6. Subjects with moderate to severe levels of PASC based on synthesis of multiple assessment modalities provided by the multispecialty study team. 7. PASC phenotype to include signs and symptoms of fatigue and low endurance and either Autonomic Disorder or Dyspnea or both. 8. Subjects who are able to comprehend the consent procedure and follow the treatment process. 9. 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. 10. 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 . 11. 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. 12. 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. 13. 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. 14. Individuals with the following Vital Signs: 1. Systolic Blood Pressure of \> 100 or \< 140 (mmHg) 2. Diastolic Blood Pressure of \> 60 or \<90 (mmHg) 3. Heart Rate of \> 60 or \< 100 (bpm) (beats per minute) 4. Temperature of \< 38°C (afebrile) 5. Respiratory Rate of \> 12 or \< 20 (bpm) (breaths per minute) 6. Pulse Ox greater than \>95% on room air 7. BMI \< 28
Exclusion criteria
5.3.7.4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Incidence of Serious Adverse Events (SAEs) | Upon completion of final post treatment clinical visit of all participants | 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. |
| Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36) | One week post administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Change in Complete blood count with differential (CBC with diff) Laboratory Testing Results | Each week for four weeks post administration | 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 |
| Assessment of Change in Lactate dehydrogenase (LDH) Laboratory Testing Results | Each week for four weeks post administration | 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 |
| Assessment of Change in Prothrombin time/partial thromboplastin time (PT/PTT Coagulation factors II) Laboratory Testing Results | Each week for four weeks post administration | 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. |
| Assessment of Change in Troponin Laboratory Testing Results | Each week for four weeks post administration | 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. |
| Assessment of Changes in Exosome/Cytokine/Chemokine Testing | Once per week for four weeks post administration | 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 |
| Assessment of Change in Fibrinogen (Coagulation factors II) Laboratory Testing Results | Each week for four weeks post administration | 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. |
| Assessment of Change in estimated glomerular filtration rate Laboratory Testing Results | Each week for four weeks post administration | 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. |
| Assessment of Change in Urinalyses Laboratory Testing Results | Each week for four weeks post administration | 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. |
| Assessment of Change in Spot creatinine Laboratory Testing Results | Each week for four weeks post administration | 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. |
| Assessment of Change in D-dimer Laboratory Testing Results | Each week for four weeks post administration | 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. |
| Assessment of change in completion time -Six-minute walk test (6MWT) | Four weeks post administration | 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. |
Contacts
Primary ContactAnthony Dudzinski
Outcome results
None listed