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

NCT ID: NCT07184385

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2027-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Long COVID Post-COVID-19 Condition Post-COVID Syndrome Post-COVID Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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REGENECYTE

HPC, Cord Blood

Group Type EXPERIMENTAL

REGENECYTE

Intervention Type BIOLOGICAL

HPC, Cord Blood

Placebo

Normal Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Normal Saline

Interventions

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REGENECYTE

HPC, Cord Blood

Intervention Type BIOLOGICAL

Placebo

Normal Saline

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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StemCyte, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ernest Lau, MS

Role: CONTACT

886-2-26013013 ext. 813

Other Identifiers

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SCUS002

Identifier Type: -

Identifier Source: org_study_id

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