Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

Brief Summary

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This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.

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Detailed Description

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Conditions

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Gonarthrosis Knee Osteoarthritis Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Protein Solution "APS(TM)"

Patients who have been treated with a single, intra-articular injection.

Group Type EXPERIMENTAL

Autologous Protein Solution "APS(TM)"

Intervention Type DEVICE

A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins

Interventions

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Autologous Protein Solution "APS(TM)"

A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Eligibility Criteria:

* Male or female ≥40 years.
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
* A standing radiograph of the knee showing a Kellgren grade of 2 or 3
* Frequency of knee pain on most days over the last month.
* Diagnosis of unilateral knee OA
* Body mass index (BMI) ≤40 kg/m2.
* Failed conservative OA therapy.
* Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
* Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
* Willingness to abstain from systemic pain medications except rescue medication.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No