Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505941
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-02
Brief Title:
Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on the Safety and Preliminary Efficacy of Umbilical Cord Mesenchymal Stem Cell Intravenous Infusion Therapy for Acute Respiratory Distress Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome consisting with two phases
Detailed Description:
The secondary objectives are to observe the preliminary efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome Phase One is an open-label dose-escalation clinical study Following safety and tolerability conclusions from Phase One and upon evaluation and approval by the data safety committee and ethics committee conduct Phase Two study which will be a randomized double-blind placebo-controlled study Dosage selection will be based on the safest and most effective dosage determined from Phase One results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None