Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04520022
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2020-08-13
Brief Title:
Safety and Effectiveness Study of Allogeneic Umbilical Cord Blood-derived Mesenchymal Stem Cell in Patients With RDEB
Sponsor:
Gangnam Severance Hospital
Organization:
Gangnam Severance Hospital
Study Overview
Official Title:
Single Center Single Group Assignment Open Label Trial to Assess Safety and Effectiveness of Intravenous Allogeneic Umbilical Cord Blood-derived Mesenchymal Stem Cell in Patients With Recessive Dystrophic Epidermolysis Bullosa
Status:
COMPLETED
Status Verified Date:
2020-08
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:
None
Brief Summary:
Previously many studies have been conducted on mesenchymal stem cells derived from bone marrow or subcutaneous fat but interest in cord blood-derived mesenchymal stem cell treatments has been increasing recently
In the case of cord blood as a source the isolation of mesenchymal stem cells is easier than bone marrow or fat tissue and cord blood-derived mesenchymal stem cells have an advantage as a treatment because they have faster population doubling time
To date no clinical research on the treatment of patients using cord blood-derived mesenchymal stem cells has been reported in the literature but there have already been registered at clinicaltrialsgov and currently being conducted overseas
In this study we will study the safety and effectiveness of RDEB patient treatment using cord blood-derived mesenchymal stem cells with these advantages
In the case of cord blood as a source the isolation of mesenchymal stem cells is easier than bone marrow or fat tissue and cord blood-derived mesenchymal stem cells have an advantage as a treatment because they have faster population doubling time
To date no clinical research on the treatment of patients using cord blood-derived mesenchymal stem cells has been reported in the literature but there have already been registered at clinicaltrialsgov and currently being conducted overseas
In this study we will study the safety and effectiveness of RDEB patient treatment using cord blood-derived mesenchymal stem cells with these advantages
Detailed Description:
Until now all clinical trials for Recessive Dystrophic Epidermolysis Bullosa RDEB have examined the potential of bone marrow-derived MSCs However umbilical cord blood UCB is another important source of stem cells since its non-invasive collection procedure and rapid availability from cord blood banking Human UCB-derived MSCs hUCB-MSCs exhibit high proliferation capacity and low immunogenicity A few data support that UCB-MSCs may have significantly greater immunosuppressive potential than other sources of MSCs A preclinical study has demonstrated that systemic infusions of human UCB-derived unrestricted somatic stem cells a subpopulation of non-hematopoietic stromal stem cells significantly extended the life span and reduced blistering of RDEB mice model Given the promising results of the preclinical study we conducted a first-in-human phase 12a clinical trial of intravenous administrations of allogeneic hUCB-MSCs in patients with RDEB to determine the safety tolerability and potential efficacy
Study Oversight
Has Oversight DMC:
None
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?:
None