SAFETY AND EFFICACY OF UNDENATURED TYPE II COLLAGEN IN OSTEOARTHRITIS

Abstract

Osteoarthritis is a degenerative joint disease causing inflammation and wear and tear of joint cartilage. UC‐II is an undenatured type II collagen derived from chicken sternum cartilage. Studies have shown efficacy of UC‐II in animal and human with a small convenient daily dose of 40 mg providing 10 mg of active type II collagen. In a human study with osteoarthritic subjects in North America, it was observed that treatment with small dose of 40 mg of UC‐II over a period of 90 days decreased WOMAC score by 33%, VAS score decreased by 40% and Lequesne score by 20%. In obese arthritic dogs, a 40 mg daily dose significantly decreased overall pain by 63%, limb manipulation decreased by 92% and lameness decreased by 78%, respectively. UC‐II was also found to be safe in liver, kidney and heart functions of dogs as demonstrated by serum ALT, BUN and CK levels. The present study examined the acute oral toxicity, acute dermal toxicity, primary dermal and primary eye irritation, and Ames' bacterial reverse mutation assay. Results indicate that LD50 OF UC‐II is greater than 5,000 mg/kg when administered orally in male and female Sprague Dawley rats. Acute dermal toxicity of UC‐II is greater than 2,000 mg/kg in both male and female rats. Primary dermal irritation in male and female New Zealand albino rabbits is slightly irritating. The overall irritation decreased within 24 hr. Primary eye irritation in albino rabbits was slightly and all animals were free of ocular irritation within 48 hrs. UC‐II did not induce mutagenic effects in the Ames' bacterial reverse mutation test in five Salmonella typhimurium strains. Taken together, these results demonstrate the broad spectrum safety and efficacy in animal and human.