NCT06156241

Stem Cell Study for Long COVID-19 Neurological Symptoms

Long COVID: Cord Tissue-Derived Mesenchymal Stromal Cells for Persistent NeuroInflammatory Symptoms

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Charles Cox · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Post-Acute COVID-19 Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Stem Cell	Stem cells derived from human cord tissue.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2023-12-05
• Last updated: 2023-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study