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

StemCyte

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Post-COVID Syndrome; Long COVID; Post-COVID Condition; Post-COVID-19 Condition

Treatments: Biological: Placebo; Biological: REGENECYTE

Study type: Interventional

Funder types: Industry

Identifiers

NCT07184385

SCUS002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

REGENECYTE

Experimental group

Description:

HPC, Cord Blood

Treatment:

Biological: REGENECYTE

Placebo

Placebo Comparator group

Description:

Normal Saline

Treatment:

Biological: Placebo