Post-Acute COVID-19 SyndromePhase 1COVID-19NCT06156241
Stem Cell Study for Long COVID-19 Neurological Symptoms
A Phase 1 study testing Stem Cell in people with Post-Acute COVID-19 Syndrome, run by Charles Cox at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post COVID-19 neurological problems. Participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- What is being tested?
- Stem Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2024to Feb 2026
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults between 18 and 55 years of age.
- Documented history of COVID-19 infection with resulting neurological sequela.
- Post-Covid-19 Functional Status score of grades 3 or 4.
- Chronic neurological symptoms defined as anxiety/depression, pain syndromes, sleep disorders, and /or memory disorders ("brain fog") persisting 6 months after an acute COVID-19 infection.
- Ability to obtain consent from the subject.
- Ability to communicate in English or Spanish (required for validated neurocognitive outcome testing).
Who cannot join
- Known history of:
- intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
- recently treated infection,
- renal disease or altered renal function (screening serum creatinine > 1.5 mg/dL),
- hepatic disease or altered liver function (screening SGPT > 150 U/L and/or T. Bilirubin >1.3 mg/dL),
- cancer,
Show all 21Show fewer
- immunosuppression (screening WBC < 3, 000 cells/ml),
- HIV+,
- chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
- acute or chronic lung disease requiring significant medication/oxygen supplementation,
- bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
- hypercoagulable disorders (Protein C, S, ATIII deficiencies), Factor V Leiden,
- known sensitivity to heparin, Lovenox, and pork products,
- individuals with mechanical prosthetic heart valves.
- Pulse oximetry oxygen saturation <93% on room air.
- Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
- For women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study.
- Previous or concurrent participation in an interventional drug or biological study.
- Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
- Unwilling or unable to return for follow-up study visits.
- Prisoner/Incarcerated.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Long COVID: Cord Tissue-Derived Mesenchymal Stromal Cells for Persistent NeuroInflammatory Symptoms
The purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post COVID-19 neurological problems. Participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. Participants will receive 1 stem cell infusion at study visit #3. Participants will have a brain PET and MRI scan at the baseline and 6mo. post-infusion visits. Follow-up safety assessments will be conducted at 6mo. and 1yr. after the stem cell infusion.
Read the detailed description
This is a non-randomized, Phase 1/2a dose escalation study using allogenic cord tissue MSC's in adults with chronic neurological symptoms following an acute COVID-19 infection.
- Conditions
- Post-Acute COVID-19 Syndrome
- Being tested
- Stem Cell
- Keywords
- Post COVID-19 Neurological Injuries
- 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.
Stem CellBiological
Also called Allogenic Human Cord Tissue Derived Mesenchymal Stromal Cells (hCTMSCs)
Stem cells derived from human cord tissue.
| Study group | Role | What they receive |
|---|---|---|
| 4x10^6 Cells/kg Dose Group | Experimental | This is a adaptive Baysian dose escalation study. The first 3 subjects will receive one stem cell infusion of 4x10^6 Cells/kg. If no infusion related AE/SAE are found, the next cohort will receive the next highest stem cell dose. Receives: Biological: Stem Cell |
| 6x10^6 Cells/kg Dose Group | Experimental | The next cohort of 3 subjects will receive one stem cell infusion of 6x10^6 Cells/kg.
If no infusion related AE/SAE are found, the next cohort will receive the next highest stem cell dose. Receives: Biological: Stem Cell |
| 8x10^6 Cells/kg Dose Group | Experimental | The next cohort of 3 subjects will receive one stem cell infusion of 8x10^6 Cells/kg.
If no infusion related AE/SAE are found, the next cohort will receive the next highest stem cell dose. Receives: Biological: Stem Cell |
| 10x10^6 Cells/kg Dose Group | Experimental | The last cohort of 3 subjects will receive one infusion of 10x10^6 Cells/kg. Receives: Biological: Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
Physical Exam
Measured: Assessed for the first 24 hours after each stem cell infusion.
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
Clinical Lab Assessments
Measured: Assessed for the first 24 hours after each stem cell infusion.
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
Vital Signs
Measured: Assessed for the first 24 hours after each stem cell infusion.
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
Subject Report of Adverse Event(s)
Measured: Assessed for the first 24 hours after each stem cell infusion.
Secondary outcomes (1)
Investigate if the hCTMSC infusions reduce the neuroinflammatory response following an acute COVID-19 infection as measured by the degree of microglial activation.
Comparison of Brain PET Scan at baseline visit and at 6 months post-infusion.
Measured: Baseline visit to 6 months post-infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID-19 SyndromeStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Non-Randomized, Phase 1/2a dose escalation using 4X10\^6/kg, 6X10\^6/kg and 8X10\^6/kg and 10X10\^10/kg cohorts of 3 patients using an adaptive Bayesian design based upon infusional toxicity/safety.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles Cox
- Sponsor type
- University, hospital or other
- Collaborators
- CBR Systems, Inc.
- Responsible party
- Sponsor-investigator, Charles Cox, The University of Texas Health Science Center, Houston
- Investigators
- Charles S. Cox, MD, Principal investigator, The Univ. of Tx. Health Science Center- Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156241
- Sponsor's protocol ID
- HSC-MS-23-xxxx
- Acronym
- COVID-19
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aiyegbusi OL, Hughes SE, Turner G, Rivera SC, McMullan C, Chandan JS, Haroon S, Price G, Davies EH, Nirantharakumar K, Sapey E, Calvert MJ; TLC Study Group. Symptoms, complications and management of long COVID: a review. J R Soc Med. 2021 Sep;114(9):428-442. doi: 10.1177/01410768211032850. Epub 2021 Jul 15.
PubMed 34265229Cha C, Baek G. Symptoms and management of long COVID: A scoping review. J Clin Nurs. 2024 Jan;33(1):11-28. doi: 10.1111/jocn.16150. Epub 2021 Dec 15.
PubMed 34913540Costas-Carrera A, Sanchez-Rodriguez MM, Canizares S, Ojeda A, Martin-Villalba I, Prime-Tous M, Rodriguez-Rey MA, Segu X, Valdesoiro-Pulido F, Borras R, Peri JM, Vieta E. Neuropsychological functioning in post-ICU patients after severe COVID-19 infection: The role of cognitive reserve. Brain Behav Immun Health. 2022 May;21:100425. doi: 10.1016/j.bbih.2022.100425. Epub 2022 Feb 7.
PubMed 35156065Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.
PubMed 34308300Del Rio C, Collins LF, Malani P. Long-term Health Consequences of COVID-19. JAMA. 2020 Nov 3;324(17):1723-1724. doi: 10.1001/jama.2020.19719. No abstract available.
PubMed 33031513Doykov I, Hallqvist J, Gilmour KC, Grandjean L, Mills K, Heywood WE. 'The long tail of Covid-19' - The detection of a prolonged inflammatory response after a SARS-CoV-2 infection in asymptomatic and mildly affected patients. F1000Res. 2020 Nov 19;9:1349. doi: 10.12688/f1000research.27287.2. eCollection 2020.
PubMed 33391730Graham EL, Clark JR, Orban ZS, Lim PH, Szymanski AL, Taylor C, DiBiase RM, Jia DT, Balabanov R, Ho SU, Batra A, Liotta EM, Koralnik IJ. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers". Ann Clin Transl Neurol. 2021 May;8(5):1073-1085. doi: 10.1002/acn3.51350. Epub 2021 Mar 30.
PubMed 33755344Hayes LD, Ingram J, Sculthorpe NF. More Than 100 Persistent Symptoms of SARS-CoV-2 (Long COVID): A Scoping Review. Front Med (Lausanne). 2021 Nov 1;8:750378. doi: 10.3389/fmed.2021.750378. eCollection 2021.
PubMed 34790680Higgins V, Sohaei D, Diamandis EP, Prassas I. COVID-19: from an acute to chronic disease? Potential long-term health consequences. Crit Rev Clin Lab Sci. 2021 Aug;58(5):297-310. doi: 10.1080/10408363.2020.1860895. Epub 2020 Dec 21.
PubMed 33347790Huang 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 33428867Ikawa M, Lohith TG, Shrestha S, Telu S, Zoghbi SS, Castellano S, Taliani S, Da Settimo F, Fujita M, Pike VW, Innis RB; Biomarkers Consortium Radioligand Project Team. 11C-ER176, a Radioligand for 18-kDa Translocator Protein, Has Adequate Sensitivity to Robustly Image All Three Affinity Genotypes in Human Brain. J Nucl Med. 2017 Feb;58(2):320-325. doi: 10.2967/jnumed.116.178996. Epub 2016 Nov 17.
PubMed 27856631Kayaaslan B, Eser F, Kalem AK, Kaya G, Kaplan B, Kacar D, Hasanoglu I, Coskun B, Guner R. Post-COVID syndrome: A single-center questionnaire study on 1007 participants recovered from COVID-19. J Med Virol. 2021 Dec;93(12):6566-6574. doi: 10.1002/jmv.27198. Epub 2021 Jul 28.
PubMed 34255355Lemhofer C, Gutenbrunner C, Schiller J, Loudovici-Krug D, Best N, Bokel A, Sturm C. Assessment of rehabilitation needs in patients after COVID-19: Development of the COVID-19-rehabilitation needs survey. J Rehabil Med. 2021 Apr 27;53(4):jrm00183. doi: 10.2340/16501977-2818.
PubMed 33764478Mandal S, Barnett J, Brill SE, Brown JS, Denneny EK, Hare SS, Heightman M, Hillman TE, Jacob J, Jarvis HC, Lipman MCI, Naidu SB, Nair A, Porter JC, Tomlinson GS, Hurst JR; ARC Study Group. 'Long-COVID': a cross-sectional study of persisting symptoms, biomarker and imaging abnormalities following hospitalisation for COVID-19. Thorax. 2021 Apr;76(4):396-398. doi: 10.1136/thoraxjnl-2020-215818. Epub 2020 Nov 10.
PubMed 33172844Malik P, Patel U, Mehta D, Patel N, Kelkar R, Akrmah M, Gabrilove JL, Sacks H. Biomarkers and outcomes of COVID-19 hospitalisations: systematic review and meta-analysis. BMJ Evid Based Med. 2021 Jun;26(3):107-108. doi: 10.1136/bmjebm-2020-111536. Epub 2020 Sep 15.
PubMed 32934000
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long COVID: Cord Tissue-Derived Mesenchymal Stromal Cells for Persistent NeuroInflammatory Symptoms
- ClinicalTrials.gov ID
- NCT06156241
- Acronym / sponsor ID
- COVID-19 / HSC-MS-23-xxxx
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- Post COVID-19 Neurological Injuries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Charles CoxUniversity, hospital or other
- Collaborators
- CBR Systems, Inc.
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 5 Dec 2023 (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 purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post COVID-19 neurological problems. Participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. Participants will receive 1 stem cell infusion at study visit #3. Participants will have a brain PET and MRI scan at the baseline and 6mo. post-infusion visits. Follow-up safety assessments will be conducted at 6mo. and 1yr. after the stem cell infusion.
Detailed description
This is a non-randomized, Phase 1/2a dose escalation study using allogenic cord tissue MSC's in adults with chronic neurological symptoms following an acute COVID-19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Non-Randomized, Phase 1/2a dose escalation using 4X10^6/kg, 6X10^6/kg and 8X10^6/kg and 10X10^10/kg cohorts of 3 patients using an adaptive Bayesian design based upon infusional toxicity/safety.
| Arm | Type | Receives |
|---|---|---|
| 4x10^6 Cells/kg Dose Group | Experimental | Biological: Stem CellThis is a adaptive Baysian dose escalation study. The first 3 subjects will receive one stem cell infusion of 4x10^6 Cells/kg. If no infusion related AE/SAE are found, the next cohort will receive the next highest stem cell dose. |
| 6x10^6 Cells/kg Dose Group | Experimental | Biological: Stem CellThe next cohort of 3 subjects will receive one stem cell infusion of 6x10^6 Cells/kg. If no infusion related AE/SAE are found, the next cohort will receive the next highest stem cell dose. |
| 8x10^6 Cells/kg Dose Group | Experimental | Biological: Stem CellThe next cohort of 3 subjects will receive one stem cell infusion of 8x10^6 Cells/kg. If no infusion related AE/SAE are found, the next cohort will receive the next highest stem cell dose. |
| 10x10^6 Cells/kg Dose Group | Experimental | Biological: Stem CellThe last cohort of 3 subjects will receive one infusion of 10x10^6 Cells/kg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults between 18 and 55 years of age.
- Documented history of COVID-19 infection with resulting neurological sequela.
- Post-Covid-19 Functional Status score of grades 3 or 4.
- Chronic neurological symptoms defined as anxiety/depression, pain syndromes, sleep disorders, and /or memory disorders ("brain fog") persisting 6 months after an acute COVID-19 infection.
- Ability to obtain consent from the subject.
Key exclusion criteria (21 listed)
- Known history of:
- Pulse oximetry oxygen saturation <93% on room air.
- Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
- For women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study.
- Previous or concurrent participation in an interventional drug or biological study.
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 |
|---|---|---|
| Stem CellAlso: Allogenic Human Cord Tissue Derived Mesenchymal Stromal Cells (hCTMSCs)Stem cells derived from human cord tissue. | Biological | 10x10^6 Cells/kg Dose Group, 4x10^6 Cells/kg Dose Group, 6x10^6 Cells/kg Dose Group, 8x10^6 Cells/kg Dose Group |
Primary outcome
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
Time frame: Assessed for the first 24 hours after each stem cell infusion.
Physical Exam
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
Time frame: Assessed for the first 24 hours after each stem cell infusion.
Clinical Lab Assessments
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
Time frame: Assessed for the first 24 hours after each stem cell infusion.
Vital Signs
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
Time frame: Assessed for the first 24 hours after each stem cell infusion.
Subject Report of Adverse Event(s)
1 secondary outcome
Investigate if the hCTMSC infusions reduce the neuroinflammatory response following an acute COVID-19 infection as measured by the degree of microglial activation.
Time frame: Baseline visit to 6 months post-infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Results publication: PubMed 34265229Aiyegbusi OL, Hughes SE, Turner G, Rivera SC, McMullan C, Chandan JS, Haroon S, Price G, Davies EH, Nirantharakumar K, Sapey E, Calvert MJ; TLC Study Group. Symptoms, complications and management of long COVID: a review. J R Soc Med. 2021 Sep;114(9):428-442. doi: 10.1177/01410768211032850. Epub 2021 Jul 15.
- Results publication: PubMed 34913540Cha C, Baek G. Symptoms and management of long COVID: A scoping review. J Clin Nurs. 2024 Jan;33(1):11-28. doi: 10.1111/jocn.16150. Epub 2021 Dec 15.
- Results publication: PubMed 35156065Costas-Carrera A, Sanchez-Rodriguez MM, Canizares S, Ojeda A, Martin-Villalba I, Prime-Tous M, Rodriguez-Rey MA, Segu X, Valdesoiro-Pulido F, Borras R, Peri JM, Vieta E. Neuropsychological functioning in post-ICU patients after severe COVID-19 infection: The role of cognitive reserve. Brain Behav Immun Health. 2022 May;21:100425. doi: 10.1016/j.bbih.2022.100425. Epub 2022 Feb 7.
- Results publication: PubMed 34308300Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.
- Results publication: PubMed 33031513Del Rio C, Collins LF, Malani P. Long-term Health Consequences of COVID-19. JAMA. 2020 Nov 3;324(17):1723-1724. doi: 10.1001/jama.2020.19719. No abstract available.
- Results publication: PubMed 33391730Doykov I, Hallqvist J, Gilmour KC, Grandjean L, Mills K, Heywood WE. 'The long tail of Covid-19' - The detection of a prolonged inflammatory response after a SARS-CoV-2 infection in asymptomatic and mildly affected patients. F1000Res. 2020 Nov 19;9:1349. doi: 10.12688/f1000research.27287.2. eCollection 2020.
- Results publication: PubMed 33755344Graham EL, Clark JR, Orban ZS, Lim PH, Szymanski AL, Taylor C, DiBiase RM, Jia DT, Balabanov R, Ho SU, Batra A, Liotta EM, Koralnik IJ. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers". Ann Clin Transl Neurol. 2021 May;8(5):1073-1085. doi: 10.1002/acn3.51350. Epub 2021 Mar 30.
- Results publication: PubMed 34790680Hayes LD, Ingram J, Sculthorpe NF. More Than 100 Persistent Symptoms of SARS-CoV-2 (Long COVID): A Scoping Review. Front Med (Lausanne). 2021 Nov 1;8:750378. doi: 10.3389/fmed.2021.750378. eCollection 2021.
- Results publication: PubMed 33347790Higgins V, Sohaei D, Diamandis EP, Prassas I. COVID-19: from an acute to chronic disease? Potential long-term health consequences. Crit Rev Clin Lab Sci. 2021 Aug;58(5):297-310. doi: 10.1080/10408363.2020.1860895. Epub 2020 Dec 21.
- Results publication: 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.
- Results publication: PubMed 27856631Ikawa M, Lohith TG, Shrestha S, Telu S, Zoghbi SS, Castellano S, Taliani S, Da Settimo F, Fujita M, Pike VW, Innis RB; Biomarkers Consortium Radioligand Project Team. 11C-ER176, a Radioligand for 18-kDa Translocator Protein, Has Adequate Sensitivity to Robustly Image All Three Affinity Genotypes in Human Brain. J Nucl Med. 2017 Feb;58(2):320-325. doi: 10.2967/jnumed.116.178996. Epub 2016 Nov 17.
- Results publication: PubMed 34255355Kayaaslan B, Eser F, Kalem AK, Kaya G, Kaplan B, Kacar D, Hasanoglu I, Coskun B, Guner R. Post-COVID syndrome: A single-center questionnaire study on 1007 participants recovered from COVID-19. J Med Virol. 2021 Dec;93(12):6566-6574. doi: 10.1002/jmv.27198. Epub 2021 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.
Charles S. Cox, MD principal investigator
The Univ. of Tx. Health Science Center- Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stem Cell in people with Post-Acute COVID-19 Syndrome, run by Charles Cox at 1 site in United States.
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 6 inclusion and 21 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Charles S. Cox, MD (713.500.7300, charles.s.cox@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product. (time frame: Assessed for the first 24 hours after each stem cell infusion.). The study lists 4 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 NCT06156241, which also lists 21 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 5 Dec 2023.