Human Umbilical Cord Mesenchymal Stem Cells (MSCs) Therapy in ARDS
NCT03608592 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2019-09-04
Summary
Acute respiratory distress syndrome (ARDS) is a devastating inflammatory and destructive disease in critical ill patients. Preclinical studies have shown a promising perspective of mesenchymal stem cells (MSCs) therapies in ARDS. But the safety and efficacy of umbilical cord MSCs (UCMSCs) have not yet been convinced in clinical trails. This study will explore the safety and life-rescue potential of UCMSCs in refracotry ARDS.
Conditions
- Acute Respiratory Distress Syndrome
Interventions
- BIOLOGICAL
-
umbilical cord derived mesenchymal stem cells (UCMSCs) suspension
Clinical grade human umbilical cord derived mesenchymal stem cells (passage 3-5) suspension are provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University. Cells are made of suspension packages (60million cells in 100ml normal saline per bag) and infused intravenously in 2 hours.
- BIOLOGICAL
-
normal saline
A bag of 100ml clinical grade normal saline are also provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Huimin Yi · The 3rd affiliated hospital of Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-01
- Primary Completion
- 2020-08-01
- Completion
- 2020-12-01
Countries
- China
Study Locations
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