APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2020-09-15

Brief Summary

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This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

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Detailed Description

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A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee who have failed at least 1 conservative OA therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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APS injection

Autologous Protein Solution

Group Type EXPERIMENTAL

APS

Intervention Type DEVICE

Intra-articular Injection

Control

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DEVICE

Intra-articular injection

Interventions

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APS

Intra-articular Injection

Intervention Type DEVICE

Saline

Intra-articular injection

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥40 years and ≤75 years.
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
* Diagnosis of knee osteoarthritis (OA) Grade 2 or 3 according to the Kellgren-Lawrence scale
* Body mass index (BMI) ≤ 40.
* Failed at least 1 conservative OA therapy
* Signed an independent ethics committee (IEC) approved informed consent form (ICF).

Exclusion Criteria

* Intra-articular Hyaluronic (HA) injection within 6 months- On Day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling).
* Presence of symptomatic OA in the non-study knee.
* Diagnosed with rheumatoid arthritis (RA), Reiter's syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease \[IBD\], sarcoidosis, or amyloidosis) or of metabolic origin.
* Diagnosis of isolated patella-femoral joint osteoarthritis.
* Valgus/varus deformity judged by the investigator to be clinically significant.
* Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee. Patients with TKR at the contra-lateral knee or THR in either hip may be enrolled provided sufficient pain relief after TKR or THR which does not require additional analgesic relief.
* Untreated acute traumatic injury of the index knee.
* Presence of a symptomatic meniscal tear in the index knee
* Limited daily activity for reasons other than OA.
* Presence of surgical hardware or other foreign body in the index knee.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No