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Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

NCT05132972 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-11-24

No results posted yet for this study

Summary

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

Conditions

  • Covid 19

Interventions

BIOLOGICAL

Normoxic Allogenic UCMSC

Allogenic umbilical cord-derived mesenchymal stem cell (UCMSC) from normoxic, culture condition, administered through intravenousinfusion at dose 1x10\^6 cells MSC/kg body weight. The treatment will be administered three times, at three days intervals (day 0, day 3, and day 6)

OTHER

Normal saline solution

Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6)

Sponsors & Collaborators

  • Dr. Moewardi General Hospital, Surakarta, Indonesia

    collaborator OTHER

  • Dr. Sardjito General Hospital, Yogyakarta, Indonesia

    collaborator UNKNOWN

  • Dr. Hasan Sadikin General Hospital, Bandung, Indonesia

    collaborator UNKNOWN

  • PT Bifarma Adiluhung

    collaborator INDUSTRY

  • Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

    lead OTHER_GOV

Principal Investigators

  • Arief Nurudin, MD PhD · Dr. Moewardi General Hospital, Surakarta, Indonesia

  • Samekto Wibowo, Prof. MD · Dr. Sardjito General Hospital, Yogyakarta, Indonesia

  • Ahmad Faried, Prof. MD · Dr. Hasan Sadikin General Hospital, Bandung, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-17
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132972 on ClinicalTrials.gov