Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03454932
Status:
TERMINATED
Last Update Posted:
2020-06-11
First Post:
2015-06-03
Brief Title:
Research Study on the Immunosuppressive Effects of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases
Sponsor:
Bone Therapeutics SA
Organization:
Bone Therapeutics SA
Study Overview
Official Title:
Laboratory Research Study of the Immunosuppressive Effect of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
limited number of recruited patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rheumatic diseases regroup a variety of disorders affecting the locomotor system including joints muscles connective tissues and soft tissues around the joints and bones Inflammation andor autoimmune reactions contribute to the aetiology of many rheumatic diseases Such autoimmune conditions commonly referred to as inflammatory rheumatic diseases IRD include arthritis of various origins such as rheumatoid arthritis RA psoriatic arthritis PsA or spondylarthritis SpA Patients with autoimmune diseases such as RA or SpA are in higher risk of fractures compared to the general population
Initial pharmacotherapies for IRD remain NSAID treatment for pain relief and anti-resorptive agents eg TNF-alpha blockers which aim at reducing bone loss and preventing occurrence of new bone erosions Yet current treatments may have strong side effects and are not always effective eg 35-40 of the patients treated with TNF-alpha inhibitors will initially or progressively loose response Therefore there is a need for further treatment modalities in IRD which would focus on both suppressing inflammation and treating bone disorders
Current research studies indicate that Bone Therapeutics allogeneic osteoblastic cells exhibit in vitro potent immunosuppressive and anti-inflammatory properties in addition to osteo-regenerative and immune-privileged properties
The present research study aims at investigating in vitro the properties of these osteoblastic cells in the context of inflammatory rheumatic diseases In this purpose in vitro assays will be used to test these immunosuppressive effects on peripheral blood mononuclear cells PBMCs of subjects diagnosed with RA PsA and SpA
Initial pharmacotherapies for IRD remain NSAID treatment for pain relief and anti-resorptive agents eg TNF-alpha blockers which aim at reducing bone loss and preventing occurrence of new bone erosions Yet current treatments may have strong side effects and are not always effective eg 35-40 of the patients treated with TNF-alpha inhibitors will initially or progressively loose response Therefore there is a need for further treatment modalities in IRD which would focus on both suppressing inflammation and treating bone disorders
Current research studies indicate that Bone Therapeutics allogeneic osteoblastic cells exhibit in vitro potent immunosuppressive and anti-inflammatory properties in addition to osteo-regenerative and immune-privileged properties
The present research study aims at investigating in vitro the properties of these osteoblastic cells in the context of inflammatory rheumatic diseases In this purpose in vitro assays will be used to test these immunosuppressive effects on peripheral blood mononuclear cells PBMCs of subjects diagnosed with RA PsA and SpA
Detailed Description:
None
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