Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 1:27 PM
Study NCT ID:
NCT04594850
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2020-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate Efficacy and Safety of of Autologous Mesenchymal Stem Cells (MSC) Injected Intracavernously
Sponsor:
Pharmicell Co., Ltd.
Organization:
Study Overview
Official Title:
An Single-blind, Multi-center, Randomization, Phase Ⅱ Study to Evaluate Efficacy and Safety of Cellgram-ED (Autologous Bone Marrow-derived Mesenchymal Stem Cells) in Erectile Dysfunction Patients With Following Radical Prostatectomy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cellgram-ED
Brief Summary:
This phase II clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.
Detailed Description:
To evaluate the efficacy and efficacy for 12 months after a single dose of Cellgram-ED in patients with erectile dysfunction after radical prostatectomy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: