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PLoS One. 2014 Feb 3;9(2):e87910. doi: 10.1371/journal.pone.0087910. eCollection 2014.

A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee.

Author information

1
Trauma Research Department, Swedish Medical Center, Englewood, Colorado, United States of America ; Trauma Research Department, St Anthony Hospital, Lakewood, Colorado, United States of America ; Ampio Pharmaceuticals, Inc., Greenwood Village, Colorado, United States of America ; Rocky Vista University, Aurora Colorado, United States of America.
2
Trauma Research Department, Swedish Medical Center, Englewood, Colorado, United States of America ; Trauma Research Department, St Anthony Hospital, Lakewood, Colorado, United States of America ; Ampio Pharmaceuticals, Inc., Greenwood Village, Colorado, United States of America.
3
Ampio Pharmaceuticals, Inc., Greenwood Village, Colorado, United States of America.
4
University Orthopaedic Center, Amherst, New York, United States of America.
5
Arthritis Treatment Center, Frederick Maryland, United States of America.
6
Central Kentucky Research Associates, Lexington, Kentucky, United States of America.
7
Center for Pharmaceutical Research, Kansas City, Missouri, United States of America.
8
Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States of America.
9
Danville Orthopeadic Clinic, Danville Virginia, United States of America.
10
Rochester Medical Research, Rochester, New York, United States of America.
11
Physician Research Collaboration, Lincoln Nebraska, United States of America.
12
Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States of America.

Abstract

OBJECTIVE:

The Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis.

METHODS:

This was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A. Patients with symptomatic knee osteoarthritis were randomized 1∶1∶1∶1 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control (saline). The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities (WOMAC) pain change from baseline over 12 weeks. Safety was examined as the incidence and severity of adverse events (AEs).

RESULTS:

A total of 329 patients were randomized and received treatment. LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (-0.93 vs -0.72; estimated difference from control: -0.25, p = 0.004); an injection volume effect was not observed (p = 0.64). The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA (Kellgren Lawrence Grade IV): the estimated difference from control was -0.42 (p = 0.02). Adverse events were generally mild and were similar in patients who received vehicle control (47%) and LMWF-5A (41%).

CONCLUSIONS:

This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01839331.

PMID:
24498399
PMCID:
PMC3912151
DOI:
10.1371/journal.pone.0087910
[Indexed for MEDLINE]
Free PMC Article
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