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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a treatment called RegeneCyte, which uses cord blood cells, to help people with ongoing symptoms after recovering from COVID-19. Participants will receive either RegeneCyte or a placebo (a harmless substitute). The goal is to determine if RegeneCyte can improve lingering post-COVID symptoms. Suitable participants include those who have experienced post-COVID syndrome and recently tested negative for COVID-19. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

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

Research has shown that RegeneCyte, a treatment derived from human umbilical cord blood, is safe and well-tolerated for individuals with post-COVID syndrome. In an earlier study, most patients experienced significant improvement in fatigue symptoms. No major safety issues emerged, indicating that the treatment is generally safe. This information may reassure those considering participation in a clinical trial for this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about RegeneCyte for Post-COVID Syndrome because it uses hematopoietic progenitor cells (HPC) from cord blood. Unlike standard treatments that primarily aim to manage symptoms, RegeneCyte potentially offers a regenerative approach, which could address underlying damage caused by COVID-19. This innovative method might accelerate recovery and improve long-term outcomes by restoring affected tissues, something current therapies do not target.

What evidence suggests that RegeneCyte might be an effective treatment for post-COVID syndrome?

Research has shown that RegeneCyte, a treatment using human umbilical cord blood, offers promising results for people with post-COVID syndrome. In one study, 85% of participants who received cord blood treatment reported complete relief from fatigue. Another study found that 90% of those treated with RegeneCyte no longer felt fatigued by the end of the trial. In this trial, some participants will receive RegeneCyte, while others will receive a placebo. These findings suggest that RegeneCyte could effectively reduce fatigue, a common symptom in post-COVID patients, and significantly improve their quality of life. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. stemcyte.com stemcyte.com/long-covidclinicaltrialresults

Post-Covid Syndrome Clinical Trial Results The results revealed significant improvements in fatigue symptoms, fatigue severity, and physical fatigue for Post-COVID patients treated with ...

2. prnewswire.com prnewswire.com/news-releases/stemcyte-announces-successful-phase-iia-clinical-trial-results-for-hpc-cord-blood-in-treating-post-covid-syndrome-85-of-patients-experience-complete-relief-from-fatigue-symptoms-302336656.html

StemCyte Announces Successful Phase IIa Clinical Trial ... This trial results demonstrated that cord blood significantly improved fatigue symptoms, with 85% of subjects in the cord blood group reporting complete relief ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07184385

NCT07184385 | A Study of Human Umbilical Cord Blood ... Study Overview. REGENECYTE (HPC, Cord Blood) for treatment in patients with post-COVID. This is a two-arm, multi-center, double-blind, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124100584

Innovative Treatment for Post-COVID Syndrome: A Clinical ... Efficacy results at week 12 reveal that 90% of RegeneCyte®-treated subjects are classified as “non-fatigue” cases, compared to 100% in the placebo group ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05682560

Study Details | NCT05682560 | Human Umbilical Cord ... This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.

6. reaganudall.org reaganudall.org/clinical-trial/human-umbilical-cord-blood-regenecyte-infusion-patients-post-covid-syndrome

Human Umbilical Cord Blood (RegeneCyte) Infusion in ... 1. Male or female aged ≥ 18. - · 2. With post-COVID syndrome. - · 3. Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test).