Stem Cell Study for Long COVID-19 Neurological Symptoms
NCT ID: NCT06156241
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2024-01-31
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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4x10^6 Cells/kg Dose Group
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.
Stem Cell
Stem cells derived from human cord tissue.
6x10^6 Cells/kg Dose Group
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.
Stem Cell
Stem cells derived from human cord tissue.
8x10^6 Cells/kg Dose Group
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.
Stem Cell
Stem cells derived from human cord tissue.
10x10^6 Cells/kg Dose Group
The last cohort of 3 subjects will receive one infusion of 10x10\^6 Cells/kg.
Stem Cell
Stem cells derived from human cord tissue.
Interventions
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Stem Cell
Stem cells derived from human cord tissue.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented history of COVID-19 infection with resulting neurological sequela.
3. Post-Covid-19 Functional Status score of grades 3 or 4.
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.
5. Ability to obtain consent from the subject.
6. Ability to communicate in English or Spanish (required for validated neurocognitive outcome testing).
Exclusion Criteria
1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
2. recently treated infection,
3. renal disease or altered renal function (screening serum creatinine \> 1.5 mg/dL),
4. hepatic disease or altered liver function (screening SGPT \> 150 U/L and/or T. Bilirubin \>1.3 mg/dL),
5. cancer,
6. immunosuppression (screening WBC \< 3, 000 cells/ml),
7. HIV+,
8. chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
9. acute or chronic lung disease requiring significant medication/oxygen supplementation,
10. bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
11. hypercoagulable disorders (Protein C, S, ATIII deficiencies), Factor V Leiden,
12. known sensitivity to heparin, Lovenox, and pork products,
13. individuals with mechanical prosthetic heart valves.
2. Pulse oximetry oxygen saturation \<93% on room air.
3. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
4. 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.
5. Previous or concurrent participation in an interventional drug or biological study.
6. Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
7. Unwilling or unable to return for follow-up study visits.
8. Prisoner/Incarcerated.
18 Years
55 Years
ALL
No
Sponsors
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CBR Systems, Inc.
OTHER
Charles Cox
OTHER
Responsible Party
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Charles Cox
The George and Cynthia Mitchell Distinguished Chair in Neurosciences Director, Children's Program in Regenerative Medicine Professor, Departments of Surgery and Pediatric Surgery UTHealth, McGovern Medical School at Houston
Principal Investigators
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Charles S. Cox, MD
Role: PRINCIPAL_INVESTIGATOR
The Univ. of Tx. Health Science Center- Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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References
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Other Identifiers
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HSC-MS-23-xxxx
Identifier Type: -
Identifier Source: org_study_id