Long COVIDPhase 1NCT05669261
Treatment of Long COVID Symptoms Utilizing Autologous Stem Cells Following COVID-19 Infection
A Phase 1 study testing Adipose Tissue Harvest and ATCell in people with Long COVID, run by American CryoStem Corporation.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- Adipose Tissue Harvest and ATCell
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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 air
- BMI < 28
Who cannot join
- 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.
Show all 37Show fewer
- 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,
- Active tuberculosis or ongoing treatment for tuberculosis or any acute or chronic infection affecting lung
- Chronic lung disease due to fibrosis or autoimmune inflammation such as sarcoidosis or rheumatoid arthritis, vasculitis or lupus
- Lung cancer
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Emphysema
- Disorders 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 functions
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A PILOT STUDY ON RESEARCH TREATMENT OF LONG COVID POST-ACUTE SEQUELAE OF SARS CoV-2 INFECTION ("PASC") USING ATCell™
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
Read the 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.
- Conditions
- Long COVID
- Being tested
- Adipose Tissue Harvest, ATCell
- Keywords
- Long COVID, Post Acute Sequelae
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Tissue HarvestProcedure or surgery
Also called Liposuction
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.
ATCellBiological
Also called Autologous Adipose Derived Mesenchymal Stem Cells
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.
| Study group | Role | What they receive |
|---|---|---|
| ATCell Treatment Group | Experimental | A single administration of expanded autologous lines at a total dose exposure of 150 million cells ("ATCell™") will be administered to this group. Receives: Procedure: Adipose Tissue Harvest; Biological: ATCell |
| Placebo | Placebo comparator | a single administration of Placebo (Sham Treatment) IV infusion of Ringers Lactate with 5% Dextrose will be administered to this group. Receives: Procedure: Adipose Tissue Harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Four weeks post administration
Secondary outcomes (11)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Each week for four weeks post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American CryoStem Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Y Dudzinski, Study director, American CryoStem Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669261
- Sponsor's protocol ID
- 0001_CRYO_LC19_ADSC_001
- Status last verified
- Jun 2023
- First submitted
- 21 Dec 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nasserie T, Hittle M, Goodman SN. Assessment of the Frequency and Variety of Persistent Symptoms Among Patients With COVID-19: A Systematic Review. JAMA Netw Open. 2021 May 3;4(5):e2111417. doi: 10.1001/jamanetworkopen.2021.11417.
PubMed 34037731Alkodaymi MS, Omrani OA, Ashraf N, Shaar BA, Almamlouk R, Riaz M, Obeidat M, Obeidat Y, Gerberi D, Taha RM, Kashour Z, Kashour T, Berbari EF, Alkattan K, Tleyjeh IM. Prevalence of post-acute COVID-19 syndrome symptoms at different follow-up periods: a systematic review and meta-analysis. Clin Microbiol Infect. 2022 May;28(5):657-666. doi: 10.1016/j.cmi.2022.01.014. Epub 2022 Feb 3.
PubMed 35124265Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, Guessous I; COVICARE TEAM. COVID-19 Symptoms: Longitudinal Evolution and Persistence in Outpatient Settings. Ann Intern Med. 2021 May;174(5):723-725. doi: 10.7326/M20-5926. Epub 2020 Dec 8. No abstract available.
PubMed 33284676Garrigues E, Janvier P, Kherabi Y, Le Bot A, Hamon A, Gouze H, Doucet L, Berkani S, Oliosi E, Mallart E, Corre F, Zarrouk V, Moyer JD, Galy A, Honsel V, Fantin B, Nguyen Y. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020 Dec;81(6):e4-e6. doi: 10.1016/j.jinf.2020.08.029. Epub 2020 Aug 25.
PubMed 32853602Ladds E, Rushforth A, Wieringa S, Taylor S, Rayner C, Husain L, Greenhalgh T. Persistent symptoms after Covid-19: qualitative study of 114 "long Covid" patients and draft quality principles for services. BMC Health Serv Res. 2020 Dec 20;20(1):1144. doi: 10.1186/s12913-020-06001-y.
PubMed 33342437Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
PubMed 33428867Jin Y, Ji W, Yang H, Chen S, Zhang W, Duan G. Endothelial activation and dysfunction in COVID-19: from basic mechanisms to potential therapeutic approaches. Signal Transduct Target Ther. 2020 Dec 24;5(1):293. doi: 10.1038/s41392-020-00454-7.
PubMed 33361764Bocci M, Oudenaarden C, Saenz-Sarda X, Simren J, Eden A, Sjolund J, Moller C, Gisslen M, Zetterberg H, Englund E, Pietras K. Infection of Brain Pericytes Underlying Neuropathology of COVID-19 Patients. Int J Mol Sci. 2021 Oct 27;22(21):11622. doi: 10.3390/ijms222111622.
PubMed 34769052Cardot-Leccia N, Hubiche T, Dellamonica J, Burel-Vandenbos F, Passeron T. Pericyte alteration sheds light on micro-vasculopathy in COVID-19 infection. Intensive Care Med. 2020 Sep;46(9):1777-1778. doi: 10.1007/s00134-020-06147-7. Epub 2020 Jun 12. No abstract available.
PubMed 32533198Jones OY, Yeralan S. Is Long COVID a State of Systemic Pericyte Disarray? J Clin Med. 2022 Jan 24;11(3):572. doi: 10.3390/jcm11030572.
PubMed 35160024Munir H, McGettrick HM. Mesenchymal Stem Cell Therapy for Autoimmune Disease: Risks and Rewards. Stem Cells Dev. 2015 Sep 15;24(18):2091-100. doi: 10.1089/scd.2015.0008. Epub 2015 Jul 28.
PubMed 26068030Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4.
PubMed 26051681Arabpour E, Khoshdel S, Tabatabaie N, Akhgarzad A, Zangiabadian M, Nasiri MJ. Stem Cells Therapy for COVID-19: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 Nov 29;8:737590. doi: 10.3389/fmed.2021.737590. eCollection 2021.
PubMed 34912818Golchin A, Seyedjafari E, Ardeshirylajimi A. Mesenchymal Stem Cell Therapy for COVID-19: Present or Future. Stem Cell Rev Rep. 2020 Jun;16(3):427-433. doi: 10.1007/s12015-020-09973-w.
PubMed 32281052
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT STUDY ON RESEARCH TREATMENT OF LONG COVID POST-ACUTE SEQUELAE OF SARS CoV-2 INFECTION ("PASC") USING ATCell™
- ClinicalTrials.gov ID
- NCT05669261
- Acronym / sponsor ID
- 0001_CRYO_LC19_ADSC_001
- Conditions
- Long COVID
- Keywords
- Long COVID, Post Acute Sequelae
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- American CryoStem CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ATCell Treatment Group | Experimental | Procedure: Adipose Tissue Harvest, Biological: ATCellA single administration of expanded autologous lines at a total dose exposure of 150 million cells ("ATCell™") will be administered to this group. |
| Placebo | Placebo comparator | Procedure: Adipose Tissue Harvesta single administration of Placebo (Sham Treatment) IV infusion of Ringers Lactate with 5% Dextrose will be administered to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose Tissue HarvestAlso: LiposuctionLocal 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. | Procedure or surgery | ATCell Treatment Group, Placebo |
| ATCellAlso: Autologous Adipose Derived Mesenchymal Stem CellsInfusion 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. | Biological | ATCell Treatment Group |
Primary outcome
Assessment of the Incidence of Serious Adverse Events (SAEs)
Time frame: 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)
Time frame: 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.
Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)
Time frame: Two weeks 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.
Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)
Time frame: Three weeks 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.
Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36)
Time frame: Four weeks 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.
11 secondary outcomes
Assessment of Changes in Exosome/Cytokine/Chemokine Testing
Time frame: Once per week for four weeks post administration
Assessment of change in completion time -Six-minute walk test (6MWT)
Time frame: Four weeks post administration
Assessment of Change in Complete blood count with differential (CBC with diff) Laboratory Testing Results
Time frame: Each week for four weeks post administration
Assessment of Change in Lactate dehydrogenase (LDH) Laboratory Testing Results
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
Time frame: Each week for four weeks post administration
Assessment of Change in Troponin Laboratory Testing Results
Time frame: Each week for four weeks post administration
Assessment of Change in D-dimer Laboratory Testing Results
Time frame: Each week for four weeks post administration
Assessment of Change in Fibrinogen (Coagulation factors II) Laboratory Testing Results
Time frame: Each week for four weeks post administration
Assessment of Change in estimated glomerular filtration rate Laboratory Testing Results
Time frame: Each week for four weeks post administration
Assessment of Change in Urinalyses Laboratory Testing Results
Time frame: Each week for four weeks post administration
Assessment of Change in Spot creatinine Laboratory Testing Results
Time frame: Each week for four weeks post administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 34037731Nasserie T, Hittle M, Goodman SN. Assessment of the Frequency and Variety of Persistent Symptoms Among Patients With COVID-19: A Systematic Review. JAMA Netw Open. 2021 May 3;4(5):e2111417. doi: 10.1001/jamanetworkopen.2021.11417.
- Background: PubMed 35124265Alkodaymi MS, Omrani OA, Ashraf N, Shaar BA, Almamlouk R, Riaz M, Obeidat M, Obeidat Y, Gerberi D, Taha RM, Kashour Z, Kashour T, Berbari EF, Alkattan K, Tleyjeh IM. Prevalence of post-acute COVID-19 syndrome symptoms at different follow-up periods: a systematic review and meta-analysis. Clin Microbiol Infect. 2022 May;28(5):657-666. doi: 10.1016/j.cmi.2022.01.014. Epub 2022 Feb 3.
- Background: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Background: PubMed 33284676Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, Guessous I; COVICARE TEAM. COVID-19 Symptoms: Longitudinal Evolution and Persistence in Outpatient Settings. Ann Intern Med. 2021 May;174(5):723-725. doi: 10.7326/M20-5926. Epub 2020 Dec 8. No abstract available.
- Background: PubMed 32853602Garrigues E, Janvier P, Kherabi Y, Le Bot A, Hamon A, Gouze H, Doucet L, Berkani S, Oliosi E, Mallart E, Corre F, Zarrouk V, Moyer JD, Galy A, Honsel V, Fantin B, Nguyen Y. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020 Dec;81(6):e4-e6. doi: 10.1016/j.jinf.2020.08.029. Epub 2020 Aug 25.
- Background: PubMed 33342437Ladds E, Rushforth A, Wieringa S, Taylor S, Rayner C, Husain L, Greenhalgh T. Persistent symptoms after Covid-19: qualitative study of 114 "long Covid" patients and draft quality principles for services. BMC Health Serv Res. 2020 Dec 20;20(1):1144. doi: 10.1186/s12913-020-06001-y.
- Background: PubMed 33428867Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
- Background: PubMed 33361764Jin Y, Ji W, Yang H, Chen S, Zhang W, Duan G. Endothelial activation and dysfunction in COVID-19: from basic mechanisms to potential therapeutic approaches. Signal Transduct Target Ther. 2020 Dec 24;5(1):293. doi: 10.1038/s41392-020-00454-7.
- Background: PubMed 34769052Bocci M, Oudenaarden C, Saenz-Sarda X, Simren J, Eden A, Sjolund J, Moller C, Gisslen M, Zetterberg H, Englund E, Pietras K. Infection of Brain Pericytes Underlying Neuropathology of COVID-19 Patients. Int J Mol Sci. 2021 Oct 27;22(21):11622. doi: 10.3390/ijms222111622.
- Background: PubMed 32533198Cardot-Leccia N, Hubiche T, Dellamonica J, Burel-Vandenbos F, Passeron T. Pericyte alteration sheds light on micro-vasculopathy in COVID-19 infection. Intensive Care Med. 2020 Sep;46(9):1777-1778. doi: 10.1007/s00134-020-06147-7. Epub 2020 Jun 12. No abstract available.
- Background: PubMed 35160024Jones OY, Yeralan S. Is Long COVID a State of Systemic Pericyte Disarray? J Clin Med. 2022 Jan 24;11(3):572. doi: 10.3390/jcm11030572.
- Background: PubMed 26068030Munir H, McGettrick HM. Mesenchymal Stem Cell Therapy for Autoimmune Disease: Risks and Rewards. Stem Cells Dev. 2015 Sep 15;24(18):2091-100. doi: 10.1089/scd.2015.0008. Epub 2015 Jul 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Y Dudzinski study director
American CryoStem Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adipose Tissue Harvest and ATCell in people with Long COVID, run by American CryoStem Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Dudzinski (1-732-747-1007, tdudzinski@americancryostem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Incidence of Serious Adverse Events (SAEs) (time frame: Upon completion of final post treatment clinical visit of all participants). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669261, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.