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Stem Cell Therapy

Stem Cell Therapy for Long COVID Syndrome (COVID-19 Trial)

Phase 1

Waitlist Available

Led By Charles S. Cox, MD

Research Sponsored by Charles Cox

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults between 18 and 55 years of age

Documented history of COVID-19 infection with resulting neurological sequela

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline visit to 6 months post-infusion.

Awards & highlights

COVID-19 Trial Summary

This trial is testing if a stem cell infusion can help people with post-COVID neurological issues. 6 clinic visits over 12-14 months; 1 stem cell infusion, brain PET & MRI scans. 6mo. & 1yr. safety assessments.

Who is the study for?

This trial is for adults aged 18-55 who have had COVID-19 and are now experiencing long-term neurological symptoms like anxiety, depression, pain, sleep issues, or 'brain fog'. They must be able to consent and communicate in English or Spanish. People with severe psychiatric conditions, recent infections, kidney/liver disease, cancer, immunosuppression including HIV+, substance dependencies that affect participation, significant lung disease requiring oxygen supplementation or medication use cannot join. Also excluded are pregnant women not using birth control and those unable to undergo required tests.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a stem cell infusion derived from human cord blood as a treatment for post-COVID-19 neurological symptoms. Participants will visit the clinic six times over about a year for monitoring which includes brain scans (PET and MRI) before treatment and six months after receiving one stem cell infusion.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site such as discomfort or pain; immune system responses like fever or chills; allergic reactions due to sensitivity to heparin used during the procedure; bleeding complications if there's an underlying disorder; plus any unforeseen risks associated with new treatments.

COVID-19 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I had COVID-19 and now have lasting nerve or brain problems.

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My health has been significantly affected by Covid-19.

COVID-19 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline visit to 6 months post-infusion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline visit to 6 months post-infusion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit to 6 months post-infusion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Investigate if the hCTMSC infusions reduce the neuroinflammatory response following an acute COVID-19 infection as measured by the degree of microglial activation.

Other outcome measures

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

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.

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

+1 more

COVID-19 Trial Design

4Treatment groups

Experimental Treatment

Group I: 8x10^6 Cells/kg Dose GroupExperimental Treatment1 Intervention

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.

Group II: 6x10^6 Cells/kg Dose GroupExperimental Treatment1 Intervention

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.

Group III: 4x10^6 Cells/kg Dose GroupExperimental Treatment1 Intervention

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.

Group IV: 10x10^6 Cells/kg Dose GroupExperimental Treatment1 Intervention

The last cohort of 3 subjects will receive one infusion of 10x10^6 Cells/kg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stem Cell

2012

Completed Phase 2

~40

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Charles CoxLead Sponsor

2 Previous Clinical Trials

CBR Systems, Inc.OTHER

1 Previous Clinical Trials

11 Total Patients Enrolled

Charles S. Cox, MDPrincipal InvestigatorThe Univ. of Tx. Health Science Center- Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit of participants in this trial strictly below forty years old?

"The trial is open to persons aged between 18 and 55. People who are younger than that have 92 other trials available, while those older than 65 can choose from 605 different options."

Answered by AI

Who can be accepted into this research program?

"To qualify for this clinical trial, applicants should possess long covid syndrome and be between 18-55 years of age. In total, 12 participants are needed to participate in the study."

Answered by AI

Is enrollment for this clinical experiment currently open?

"This therapy trial, first posted on January 1st 2024 and last updated November 29th 2023 is not currently recruiting patients. Though there are 685 other active trials looking for participants at this time."

Answered by AI