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Hyaluronic Acid
A-CP HA Kit for Osteoarthritis
N/A
Waitlist Available
Led By Nicholas Sgaglione, MD
Research Sponsored by Regen Lab SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial shows that for patients with osteoarthritis who haven't found relief from other treatments, a combination of hyaluronic acid and platelet-rich plasma may help.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Variation in overall OA-related symptoms
Variation in pain at walking (WOMAC A1 score)
Secondary outcome measures
% of OMERACT-OARSI responders
Patient's global assessment on a 7-point scale
Patient's global assessment on a 7-point scale at Month 1 (D30), Month 2, Mont 3, Month 4, Month 6, and Month 12 Clinician's global assessment on a 7-point scale
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: A-CP HAExperimental Treatment1 Intervention
Patients randomized in this group will be treated with a combination of platelet-rich plasma plus hyaluronic acid prepared with A-CP HA Kit.
Group II: ArthroVisc 40Active Control1 Intervention
Patients randomized in this group will be treated with hyaluronic acid only (ArthroVisc 40); hyaluronic acid is the same as the one contained in the A-CP HA Kit.
Group III: PlaceboPlacebo Group1 Intervention
Patients randomized in this group will be treated with a saline solution.
Find a Location
Who is running the clinical trial?
Regen Lab SALead Sponsor
11 Previous Clinical Trials
1,125 Total Patients Enrolled
3 Trials studying Osteoarthritis
670 Patients Enrolled for Osteoarthritis
Nicholas Sgaglione, MDPrincipal InvestigatorNorthwell Health
Bert Mandelbaum, MDPrincipal InvestigatorSanta Monica Orthopaedic & Sports Medicine Group
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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