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.
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.


BACKGROUND
ClinicalTrials.gov NCT01839331.
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.
David
D
Bar-Or
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.
Kristin M
KM
Salottolo
Ampio Pharmaceuticals, Inc., Greenwood Village, Colorado, United States of America.
Holli
H
Loose
University Orthopaedic Center, Amherst, New York, United States of America.
Matthew J
MJ
Phillips
University Orthopaedic Center, Amherst, New York, United States of America.
Brian
B
McGrath
Arthritis Treatment Center, Frederick Maryland, United States of America.
Nathan
N
Wei
Central Kentucky Research Associates, Lexington, Kentucky, United States of America.
James L
JL
Borders
Center for Pharmaceutical Research, Kansas City, Missouri, United States of America.
John E
JE
Ervin
Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States of America.
Alan
A
Kivitz
Danville Orthopeadic Clinic, Danville Virginia, United States of America.
Mark
M
Hermann
Rochester Medical Research, Rochester, New York, United States of America.
Tammi
T
Shlotzhauer
Physician Research Collaboration, Lincoln Nebraska, United States of America.
Melvin
M
Churchill
Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States of America.
Donald
D
Slappey
Ampio Pharmaceuticals, Inc., Greenwood Village, Colorado, United States of America.
Vaughan
V
Clift
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D008970:Molecular Weight; D020370:Osteoarthritis, Knee / Q000150:complications*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D012709:Serum Albumin / Q000008:administration & dosage*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D012709:Serum Albumin