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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a stem cell therapy to determine if it can safely assist individuals with ongoing neurological issues after COVID-19. The study targets those with symptoms such as anxiety, depression, chronic pain, sleep problems, or "brain fog" persisting for at least six months post-infection. Participants will receive one stem cell infusion and undergo several health checks over a year. The trial suits adults who have had COVID-19 and face these persistent neurological problems. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that stem cell therapy is generally safe for humans. One review found that stem cells can safely lower death rates and reduce illness severity in COVID-19 patients. Another study found that stem cell therapy helped reduce inflammation and speed up lung recovery in these patients, with no major short-term safety concerns.

Additionally, a study on long COVID patients examined the safety of mesenchymal stem cell therapy. It found that the treatment was safe and helped reduce inflammation linked to brain damage. These findings suggest that the stem cell treatment being tested for long COVID is likely well-tolerated. However, as this is an early phase trial, the primary goal is to assess its safety and identify any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about stem cell therapy for Long COVID because it offers a novel approach that differs from current treatments like symptom management and rehabilitation exercises. Unlike these standard methods, stem cell therapy aims to repair and regenerate damaged tissues by using the body's own cells. This innovative mechanism could potentially address the root cause of Long COVID symptoms, rather than just alleviating them. Additionally, stem cell therapy is administered through a single infusion, which might offer a more convenient and efficient treatment option for patients.

What evidence suggests that stem cell therapy might be an effective treatment for Long COVID?

Research has shown that stem cell therapy might alleviate Long COVID symptoms, particularly those affecting the brain and nerves. Studies have indicated that mesenchymal stem cells can aid lung healing and might improve the quality of life for Long COVID patients. Long-term safety has been confirmed in patients with severe COVID-19, with some experiencing positive effects for several years. While the primary focus has been on lung recovery, researchers are also exploring how this therapy might address other issues, such as those affecting the brain. This suggests that stem cells could be promising for treating post-COVID problems, but further research is needed for confirmation.

In this trial, participants will receive varying doses of stem cell infusions to evaluate their safety and effectiveness. The study includes several dose groups, ranging from 4x10^6 Cells/kg to 10x10^6 Cells/kg, to determine the optimal dose for treating Long COVID symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Charles S. Cox, MD

Principal Investigator

The Univ. of Tx. Health Science Center- Houston

Are You a Good Fit for This Trial?

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

Chemical or ETOH dependency that would preclude participation in the study

I have cancer.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40001244/

Long-term outcomes of mesenchymal stem cell therapy in ... MSC treatment may offer potential benefits for lung recovery and improved quality of life in patients experiencing Long COVID symptoms. Trial ...

2. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04148-1

3-year follow-up of a randomized, double-blind, placebo ... These findings support the long-term safety of MSC therapy in patients with severe COVID-19 over 3 years. MSC treatment may offer potential benefits for lung ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05669261

Study: Treatment for Long COVID Symptoms with Stem Cells A PILOT STUDY ON RESEARCH TREATMENT OF LONG COVID POST-ACUTE SEQUELAE OF SARS CoV-2 INFECTION ("PASC") USING ATCell™. Conditions. Long COVID. Long COVID. Long ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10813738/

Mesenchymal Stem Cell-Based Therapies in the Post-Acute ... Mesenchymal stem cell-based therapies in the post-acute neurological COVID syndrome: current landscape and opportunities.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06492798

Effectiveness and Safety of Mesenchymal Stem Cell ... The study confirmed that UC-MSCs therapy, as an adjuvant therapy, has long-term benefits for lung injury in severe COVID-19 patients. This was a randomized, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8666565/

Stem Cells Therapy for COVID-19: A Systematic Review ... In the current study, we found that stem cells are safe and can significantly decrease the mortality and morbidity of patients with COVID-19. Stem cell infusion ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1465324925006772

Impact of mesenchymal stromal/stem cell infusions on ... MSC in COVID-19 patients resulted safe and feasible, effectively modulating inflammatory cytokines, in particular mitigating brain damage related biomarker.