Status:
NOT_YET_RECRUITING
Stem Cell Study for Long COVID-19 Neurological Symptoms
Lead Sponsor:
Charles Cox
Collaborating Sponsors:
CBR Systems, Inc.
Conditions:
Post-Acute COVID-19 Syndrome
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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. Participa...
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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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,
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06156241
Start Date
January 1 2024
End Date
February 1 2026
Last Update
December 5 2023
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030