Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-28 @ 10:55 PM
Study NCT ID:
NCT02844751
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
Sponsor:
VivaTech International, Inc.
Organization:
Study Overview
Official Title:
Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee
Status:
RECRUITING
Status Verified Date:
2025-10
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:
This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.
Detailed Description:
This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.
Patients will be treated for Osteoarthritis (OA) of the knee due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints.
Cohort 1 will include PRP treatments at time of initial StroMed treatment plus at 1 week, 2 weeks and 1 month.
Cohort 2 will include PRP treatments at time of initial StroMed treatment plus at 1 month and 2 months.
Patient outcomes will be tracked with a follow up MRI at various endpoints to 6 months, laboratory tests for inflammation markers, and knee injury and osteoarthritis outcome score (KOOS) questionnaires. SF-36 forms (a quality of life measure) and numerical rating scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending knee replacement therapy.
Patients will be treated for Osteoarthritis (OA) of the knee due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints.
Cohort 1 will include PRP treatments at time of initial StroMed treatment plus at 1 week, 2 weeks and 1 month.
Cohort 2 will include PRP treatments at time of initial StroMed treatment plus at 1 month and 2 months.
Patient outcomes will be tracked with a follow up MRI at various endpoints to 6 months, laboratory tests for inflammation markers, and knee injury and osteoarthritis outcome score (KOOS) questionnaires. SF-36 forms (a quality of life measure) and numerical rating scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending knee replacement therapy.
Study Oversight
Has Oversight DMC:
True
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?: