NCT07184385

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
17mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

September 17, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

September 17, 2025

Last Update Submit

September 18, 2025

Conditions

Long COVIDPost-COVID-19 ConditionPost-COVID SyndromePost-COVID Condition

Keywords

Post-COVID conditionPost-COVID syndromeLong COVIDREGENECYTEPost-COVID fatigueUmbilical cord blood

Outcome Measures

Primary Outcomes (1)

  • The change of efficacy

    Change of efficacy evaluation

    Week

Secondary Outcomes (1)

  • Treatment-emergent adverse events (TEAEs)

    Week

Study Arms (2)

REGENECYTE

EXPERIMENTAL

HPC, Cord Blood

Biological: REGENECYTE

Placebo

PLACEBO COMPARATOR

Normal Saline

Biological: Placebo

Interventions

REGENECYTEBIOLOGICAL

HPC, Cord Blood

REGENECYTE
PlaceboBIOLOGICAL

Normal Saline

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ernest Lau, MS

CONTACT

886-2-26013013Sct_pCOV02@stemcyte.com.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 19, 2025

Study Start

March 31, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

September 23, 2025

Record last verified: 2025-09