Phase 1 safety and tolerability study of BMP-7 in symptomatic knee osteoarthritis.

ABSTRACT:

Background

There are no proven therapies that modify the structural changes associated with osteoarthritis (OA). Preclinical data suggests that intra-articular recombinant human BMP-7 (bone morphogenetic protein-7) has reparative effects on cartilage, as well as on symptoms of joint pain. The objective of this study was to determine the safety and tolerability as well as dose-limiting toxicity and maximal tolerated dose of intra-articular BMP-7. The secondary objectives were to determine the effect on symptomatic responses through 24 weeks.

Methods

This was a Phase 1, double-blind, randomized, multi-center, placebo-controlled, single-dose escalation safety study consisting of 4 dosing cohorts in participants with knee OA. Each cohort was to consist of 8 treated participants,

SUBMITTER: Hunter DJ 

PROVIDER: S-EPMC2958989 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature