RegeneCyte for Post-COVID Syndrome

Overseen By Bobo Chen, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: StemCyte International, Ltd.

Disqualifiers: Neurological disorders, Terminal illness, Immune disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

30 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

What data supports the effectiveness of the treatment RegeneCyte for Post-COVID Syndrome?

Research shows that mesenchymal stem cells (MSCs), which are often used in regenerative medicine, can help with wound healing and tissue repair by promoting new blood vessel formation and reducing inflammation. This suggests that treatments like RegeneCyte, which may involve similar components, could potentially aid in recovery from conditions like Post-COVID Syndrome. ^{1 2 3 4 5}

How is the treatment RegeneCyte different from other treatments for Post-COVID Syndrome?

RegeneCyte is unique because it uses regenerative medicine approaches, such as stem cells and exosomes, to help repair and regenerate damaged tissues, which is different from traditional treatments that may not focus on tissue regeneration. This approach aims to restore normal tissue function by stimulating the body's own repair processes or using transplanted cells. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing a treatment using stem cells from umbilical cord blood in patients who have ongoing symptoms after recovering from COVID-19. The stem cells may help the body heal by repairing damaged tissues and reducing inflammation. The study will compare the effects of this treatment to another group. These stem cells have shown promise in reducing mortality and improving lung symptoms in COVID-19 patients.

Eligibility Criteria

This trial is for adults over 18 who have post-COVID syndrome and can commit to the study's requirements. They must test negative for COVID-19 before joining. People with neurological issues predating COVID, recent vaccinations, participation in other studies, immune diseases, terminal illnesses or pregnancy/breastfeeding cannot join.

Inclusion Criteria

You need to have a negative COVID-19 test taken within the last 7 days.

Able to provide signed informed consent (by the subject or his/her legally authorized representative)

I am experiencing long-term effects after recovering from COVID-19.

Exclusion Criteria

I have not had any vaccinations in the last 3 weeks.

I had a neurological disorder before getting COVID-19.

You may have medical conditions that could make the study risky, as determined by the doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either RegeneCyte or placebo infusion

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• RegeneCyte

Trial Overview The trial is testing RegeneCyte (a human umbilical cord blood treatment) against a placebo to see if it helps patients with post-COVID syndrome. Participants will receive either the real treatment or a placebo without knowing which one they are getting.

Participant Groups

Group I: REGENECYTE Experimental Treatment 1 Intervention

HPC, Cord Blood

Group II: Placebo Placebo Group 1 Intervention

Normal Saline

Who Is Running the Clinical Trial?

StemCyte International, Ltd.

Lead Sponsor

Trials

4

Recruited

90+

StemCyte, Inc.

Lead Sponsor

Trials

6

Recruited

110+

StemCyte Taiwan Co., Ltd.

Industry Sponsor

Trials

5

Recruited

90+

References

1. England pubmed.ncbi.nlm.nih.gov

Combined platelet-rich plasma and lipofilling treatment provides great improvement in facial skin-induced lesion regeneration for scleroderma patients. [2018]

2. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Adipose-derived mesenchymal stem cells and wound healing: Potential clinical applications in wound repair. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

MSCs seeded on bioengineered scaffolds improve skin wound healing in rats. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of MSC in Wound Healing, Scarring and Regeneration. [2021]

5. Poland pubmed.ncbi.nlm.nih.gov

Efficacy of erythropoietin-pretreated mesenchymal stem cells in murine burn wound healing: possible in vivo transdifferentiation into keratinocytes. [2020]

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

Regenerative Medicine Approaches in COVID-19 Pneumonia. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

Perspectives on Stem Cell-Based Regenerative Medicine with a Particular Emphasis on Mesenchymal Stem Cell Therapy. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

[Regenerative medicine: history and perspectives]. [2011]

9. Ireland pubmed.ncbi.nlm.nih.gov

Stem cells and the frontiers of neonatology. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Regenerative therapy by fusion of medicine and engineering: First-in-human clinical trials with induced pluripotent stem cells and cell sheet technology: A report of the Symposium of Regenerative Medicine for Patients. [2020]