Official Title
Long COVID: Cord Tissue-Derived Mesenchymal Stromal Cells for Persistent NeuroInflammatory Symptoms
Brief Summary

The purpose of this research study is to test the safety and benefit of a human cordblood derived stem cell infusion as a treatment for individuals with post COVID-19neurological problems. Participants in the study will have 6 clinic visits over a 12 to14 mo. period with each visit lasting 2 to 6 hours. Participants will receive 1 stem cellinfusion at study visit #3. Participants will have a brain PET and MRI scan at thebaseline and 6mo. post-infusion visits. Follow-up safety assessments will be conducted at6mo. 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.

Not yet recruiting
Post-acute COVID-19 Syndrome

Biological: Stem Cell

Stem cells derived from human cord tissue.
Other Name: Allogenic Human Cord Tissue Derived Mesenchymal Stromal Cells (hCTMSCs)

Eligibility Criteria

Inclusion Criteria:

1. Adults between 18 and 55 years of age.

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. Known history of:

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Countries
United States
Locations

The University of Texas Health Science Center at Houston
Houston, Texas, United States

Contacts

Charles S. Cox, MD
713.500.7300
charles.s.cox@uth.tmc.edu

Carmen Duron, MHA, RN
713.500.7395
maria.carmen.duron@uth.tmc.edu

Charles S. Cox, MD, Principal Investigator
The Univ. of Tx. Health Science Center- Houston

CBR Systems, Inc.
NCT Number
Keywords
Post COVID-19 Neurological Injuries
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome