Stem Cell Study for Long COVID-19 Neurological Symptoms (COVID-19)

November 29, 2023 updated by: Charles Cox

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Stem Cell
Stem cells derived from human cord tissue.
Other Names:
  • Allogenic Human Cord Tissue Derived Mesenchymal Stromal Cells (hCTMSCs)
Experimental: 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.
Biological: Stem Cell
Stem cells derived from human cord tissue.
Other Names:
  • Allogenic Human Cord Tissue Derived Mesenchymal Stromal Cells (hCTMSCs)
Experimental: 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.
Biological: Stem Cell
Stem cells derived from human cord tissue.
Other Names:
  • Allogenic Human Cord Tissue Derived Mesenchymal Stromal Cells (hCTMSCs)
Experimental: 10x10^6 Cells/kg Dose Group
The last cohort of 3 subjects will receive one infusion of 10x10^6 Cells/kg.
Biological: Stem Cell
Stem cells derived from human cord tissue.
Other Names:
  • Allogenic Human Cord Tissue Derived Mesenchymal Stromal Cells (hCTMSCs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: Assessed for the first 24 hours after each stem cell infusion.
Clinical Lab Assessments
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.
Time Frame: Assessed for the first 24 hours after each stem cell infusion.
Vital Signs
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.
Time Frame: Assessed for the first 24 hours after each stem cell infusion.
Subject Report of Adverse Event(s)
Assessed for the first 24 hours after each stem cell infusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Comparison of Brain PET Scan at baseline visit and at 6 months post-infusion.
Baseline visit to 6 months post-infusion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obtain treatment effect estimates on the structural integrity of the corpus callosum measured by changes in fractional anisotropy (FA).
Time Frame: Baseline visit to 6 months post-infusion.
Comparison of Brain DT-MRI at baseline visit and at 6 month post-infusion.
Baseline visit to 6 months post-infusion.
Obtain treatment effect estimates on the structural integrity of the corpus callosum measured by mean diffusivity (MD). MD is an inverse measure of membrane density, and is sensitive to edema and necrosis.
Time Frame: Baseline visit to 6 months post-infusion.
Comparison of Brain DT-MRI at baseline visit and at 6 month post-infusion.
Baseline visit to 6 months post-infusion.
Obtain treatment effect estimates on the structural integrity of the corticospinal tracts measured by fractional anisotropy (FA).
Time Frame: Baseline visit to 6 months post-infusion.
Comparison of Brain DT-MRI at baseline visit and at 6 month post-infusion.
Baseline visit to 6 months post-infusion.
Obtain treatment effect estimates on the structural integrity of the corticospinal tracts measured by mean diffusivity (MD). MD is an inverse measure of membrane density, and is sensitive to edema and necrosis.
Time Frame: Baseline visit to 6 months post-infusion.
Comparison of Brain DT-MRI at baseline visit and at 6 month post-infusion.
Baseline visit to 6 months post-infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles Cox

Collaborators

CBR Systems, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-23-xxxx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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