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NCT Number: NCT07184385

A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition

REGENECYTE (HPC, Cord Blood) for treatment in patients with post-COVID.

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Key information

Conditions

Long COVID COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-COVID Condition Post-COVID Syndrome Post-COVID-19 Condition Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This is a two-arm, multi-center, double-blind, randomized, placebo-controlled phase III study. A total of 60 subjects with post-COVID will be enrolled.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged ≥ 18
  • With post-COVID condition
  • Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
  • Able to provide signed informed consent (by the subject or his/her legally authorized representative)
  • Is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent

Exclusion criteria

  • Neurological disorders prior to COVID-19 diagnosis
  • With pre-existing terminal illness
  • With known immune disease
  • Is pregnant or breastfeeding
  • Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
  • Has received any vaccination within 3 weeks prior to the first IP infusion or planning to receive vaccination during the treatment period
  • Judged by the investigator to be not suitable for study participation, including but not limited to pre-existing chronic diseases
  • Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters

Treatment and study plan

REGENECYTE

Biological

HPC, Cord Blood

Placebo

Biological

Normal Saline

Primary outcomes

  1. The change of efficacy

    Time frame: Week

    Change of efficacy evaluation

Secondary outcomes

  1. Treatment-emergent adverse events (TEAEs)

    Time frame: Week

    Incidence of treatment-emergent adverse events (TEAEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Ernest Lau, MS

CONTACT

[email protected]

886-2-26013013 ext. 813

Sponsors and collaborators

Lead sponsor

StemCyte, Inc.

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Phase III Study to Assess the Efficacy of Human Umbilical Cord Blood (REGENECYTE) Infusion in Reducing Fatigue in Post-COVID Condition

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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