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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Variation in overall OA-related symptoms

Variation in pain at walking (WOMAC A1 score)

Secondary study objectives

% 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 more

Trial 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.

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