Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

National Research and Innovation Agency (BRIN)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Covid 19

Treatments: Biological: Normoxic Allogenic UCMSC; Other: Normal saline solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05132972

BRIN20211118a

Details and patient eligibility

About

This study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe COVID-19 patients. Here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms

Full description

This is a randomized controlled trial. double-blind, multi-center clinical study conducted at three different hospitals, on 21 patients who received intervention and 21 patients who received control treatment. The purpose of this study is to evaluate the efficacy and safety of intravenous administration of normoxic allogeneic umbilical cord-derived mesenchymal stem cell (UCMSC) in the treatment group, compared to the control group who are only given standard COVID-19 treatments and normal saline infusion

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Man or woman age 18-75 years
• SARS-CoV2 positive as confirmed by SARS-CoV2 RT-PCR Test
• Diagnosed with pnumonia as confirmed by chect radiography and history of fever, coug with one of the following symptoms: RR > 30x per minute, SaO2 93%, FaO2/FiO2 300 mmHg
• Voluntarily joined the clinical trial and has signed the informed consent form

Exclusion criteria

• Pregnant and lactating woman
• Patient who are diagnosed or have history of tumor and cancer
• Patient whose mother or sister are diagnosed with breast or ovarian cancer
• Level of SGPT/ALT is ≥ 5 times upper limit from normal value
• Level of eGFR is < 30 ml/min
• Reluctant to sign informed consent and unwilling to take the required tests
• Require invasive ventilation
• Shock
• Organ failure
• Currently involve in other clinical trial, or join another clinical trial in the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

42 participants in 2 patient groups

Treatment

Experimental group

Description:

Group receiving standard COVID-19 treatment and UCMSC infusion

Treatment:

Biological: Normoxic Allogenic UCMSC

Control

Sham Comparator group

Description:

Group receiving standard COVID-19 treatment and normal saline infusion

Treatment:

Other: Normal saline solution