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OpenTrials
Completed

NCT Number: NCT05682560

Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome

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

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)
  • 4. Able to provide signed informed consent (by the subject or his/her legally authorized representative)
  • 5. 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

  • 1. Neurological disorders prior to COVID-19 diagnosis
  • 2. With pre-existing terminal illness
  • 3. With known immune disease
  • 4. Is pregnant or breastfeeding
  • 5. Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
  • 6. Has received any vaccination within 3 weeks prior to the first IP infusion
  • 7. Judged by the investigator to be not suitable for study participation
  • 8. 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. Treatment-emergent adverse events (TEAEs)

    Time frame: Baseline to Week 26

    Incidence of treatment-emergent adverse events (TEAEs)

Secondary outcomes

  1. Change of fatigue score as measured by CFQ-11

    Time frame: Baseline, Week 6, 12, 18 and 26

Sponsors and collaborators

Lead sponsor

StemCyte, Inc.

Industry

Collaborators

  • StemCyte Taiwan Co., Ltd.

Registry information

Official study title

A Randomized Controlled Phase IIa, Two-arm Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 12, 2023
Registry last updated
Mar 24, 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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