Stem Cell Therapy for Long COVID Syndrome

(COVID-19 Trial)

Overseen By Carmen Duron, MHA, RN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Charles Cox

Must not be taking: Heparin, Lovenox

Disqualifiers: Renal disease, Hepatic disease, Cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 visit

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

What data supports the effectiveness of the treatment Stem Cell Therapy for Long COVID Syndrome?

Research shows that mesenchymal stem cell therapy has been studied for severe COVID-19 patients, with follow-up results indicating potential benefits. Additionally, adipose-derived mesenchymal stem cells have been evaluated for improving symptoms in post-COVID-19 syndrome, suggesting possible effectiveness for long COVID. ^{1 2 3 4 5}

Is stem cell therapy safe for humans?

Research on stem cell therapy, particularly using mesenchymal stem cells (MSCs), shows it is generally safe for humans. Studies on COVID-19 patients found no serious side effects, with only minor issues like temporary fever or facial flushing in some cases. ^{1 4 6 7 8}

How is stem cell treatment different for Long COVID?

Stem cell treatment for Long COVID is unique because it uses mesenchymal stem cells (MSCs) to repair damaged tissues and modulate the immune system, which is different from other treatments that may not address tissue repair or immune regulation. This approach is particularly promising for conditions like Long COVID, where persistent symptoms may result from immune dysregulation and tissue damage. ^{1 4 9 10 11}

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

My health has been significantly affected by Covid-19.

I've had symptoms like anxiety, pain, sleep issues, or 'brain fog' for 6 months after COVID-19.

Exclusion Criteria

Prisoner/Incarcerated

I have cancer.

Chemical or ETOH dependency that would preclude participation in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline brain PET and MRI scans

1 visit

1 visit (in-person)

Treatment

Participants receive one stem cell infusion at study visit #3

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including brain PET and MRI scans at 6 months post-infusion

12-14 months

4 visits (in-person)

Treatment Details

Interventions

• Stem Cell

Trial Overview 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.

Participant Groups

Group I: 8x10^6 Cells/kg Dose Group Experimental Treatment 1 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 Group Experimental Treatment 1 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 Group Experimental Treatment 1 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 Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Charles Cox

Lead Sponsor

Trials

3

Recruited

10+

CBR Systems, Inc.

Collaborator

Trials

2

Recruited

20+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Human mesenchymal stem cell therapy in severe COVID-19 patients: 2-year follow-up results of a randomized, double-blind, placebo-controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Adipose-derived, autologous mesenchymal stem cell therapy for patients with post-COVID-19 syndrome: an intermediate-size expanded access program. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Persistent SARS-CoV-2 PCR Positivity Despite Anti-viral Treatment in Immunodeficient Patients. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Circulating haematopoietic stem cells and long-term outcomes of COVID-19. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of cell therapy for COVID-19: global clinical trial landscape, published safety/efficacy outcomes, cell product manufacturing and clinical delivery. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Human umbilical cord-derived mesenchymal stem cell therapy in patients with COVID-19: a phase 1 clinical trial. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Mesenchymal Stem Cell Therapy for COVID-19-Induced ARDS Patients: A Case Report. [2022]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Stem Cell Therapy: A Promising Approach in Treatment of COVID-19. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Safety and long-term improvement of mesenchymal stromal cell infusion in critically COVID-19 patients: a randomized clinical trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell research progress for the treatment of COVID-19. [2020]