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

Long COVID Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682560
• Other study ID #: SCUS001
• Status: Recruiting
• Phase: Phase 2
• Start date: May 4, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2023
• Source: StemCyte, Inc.
• Contact: Bobo Chen, PhD
• Phone: 02-26558558
• Email: Sct_pCOV01[@]stemcyte.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a two-arm, multi-national, multi-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Long COVID
• Syndrome

Intervention

Biological:
• RegeneCyte
HPC, Cord Blood

Other:
• Placebo
Normal Saline

Locations

Country	Name	City	State
United States	Myrak Research Center	Miami Lakes	Florida

Sponsors (1)

Lead Sponsor	Collaborator
StemCyte, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events (TEAEs)	Week 48
Secondary	The change of efficacy	Change of efficacy evaluation	Week 48