Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-12-14
Brief Title:
Bone Marrow Aspirate Concentrate BMAC Treatment for Knee Osteoarthritis
Sponsor:
CELL Technologies Inc
Organization:
CELL Technologies Inc
Study Overview
Official Title:
Bone Marrow Aspirate ConCentrate for the Treatment of knEe Osteoarthritis A Phase III muLti-centER Pan-cAnadian prospecTivE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ACCELERATE3
Brief Summary:
The purpose of the ACCELERATE3 trial is to assess the efficacy of a single intra-articular IA injection of autologous BMAC in one or both knees compared to a single IA injection of Standard of Care SOC in patients with mild to severe knee OA
Detailed Description:
A Pan-Canadian Phase 3 open-label randomized trial of bone marrow aspirate concentrate BMAC administration in patients with mild to severe knee OA A total of 374 eligible patients will be randomized to BMAC or Standard of Care SOC Patients randomized to the interventional arm BMAC will have a sample of bone marrow taken from their pelvic region and processed at the bedside for immediate delivery back to the patient via intra-articular IA injection into one or both knees
All randomized patients will be followed for 48 weeks Blood will be collected at scheduled visits for analysis Adverse events will be monitored throughout the trial Assessments will be performed by physical exam and standardized questionnaires related to the physical function health and pain of each participant will be conducted
All randomized patients will be followed for 48 weeks Blood will be collected at scheduled visits for analysis Adverse events will be monitored throughout the trial Assessments will be performed by physical exam and standardized questionnaires related to the physical function health and pain of each participant will be conducted
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