Stem Cell Study for Long COVID-19 Neurological Symptoms

NCT06156241 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HSC-MS-23-xxxx
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

Post COVID-19 Neurological Injuries

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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)

  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.

  Baseline visit to 6 months post-infusion.

Other Outcomes (4)

• Obtain treatment effect estimates on the structural integrity of the corpus callosum measured by changes in fractional anisotropy (FA).

  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.

  Baseline visit to 6 months post-infusion.

• Obtain treatment effect estimates on the structural integrity of the corticospinal tracts measured by fractional anisotropy (FA).

  Baseline visit to 6 months post-infusion.

Study Arms (4)

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.

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.

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.

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.

Biological: Stem Cell

Interventions

Stem Cell BIOLOGICAL

Stem cells derived from human cord tissue.

Also known as: Allogenic Human Cord Tissue Derived Mesenchymal Stromal Cells (hCTMSCs)

10x10^6 Cells/kg Dose Group; 4x10^6 Cells/kg Dose Group; 6x10^6 Cells/kg Dose Group; 8x10^6 Cells/kg Dose Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles Cox: lead
• CBR Systems, Inc.: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles S. Cox, MD

  The Univ. of Tx. Health Science Center- Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles S. Cox, MD

CONTACT

713.500.7300; charles.s.cox@uth.tmc.edu

Carmen Duron, MHA, RN

CONTACT

713.500.7395; maria.carmen.duron@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 5, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)