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

Recruiting in Palo Alto (17 mi)

Overseen byCharles S. Cox, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Charles Cox

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Charles S. Cox, MD

Principal Investigator

The Univ. of Tx. Health Science Center- Houston

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 55 years old.

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

My health has been significantly affected by Covid-19.

See 3 more

Exclusion Criteria

Prisoner/Incarcerated

I have cancer.

Chemical or ETOH dependency that would preclude participation in the study

See 17 more

Treatment Details

Interventions

Stem Cell (Stem Cell Therapy)

Trial OverviewThe 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.

Participant Groups

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.