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Amelioration of human osteoarthritis symptoms with topical 'biotherapeutics': a phase I human trial
Fadia F Mahmoud1, Adel M Al-Awadhi, David D Haines
1Department of Medical Laboratory Sciences, Faculty of Allied Health Sciences, Kuwait University, The 4th Ring Road, Jabryia, P.O. Box 31470, Sulaibikhat, Kuwait, 90805, fadia@hsc.edu.kw.
Abstract:
Osteoarthritis (OA) treatments presently rely on analgesics, which manage pain but fail to restore imbalances between catabolic and anabolic processes that underlie OA pathogenesis. Recently, biologic (biotherapeutic) drugs, which alter the activity of catabolic agents such as nitric oxide and inflammatory cytokines in ways, allowing tissue regeneration, were evaluated for efficacy in OA treatment. These studies failed to demonstrate dramatic abatement of OA symptoms by these drugs, but suggested strategies by which biologic agents might be used to treat OA. The present review summarizes current understanding of OA pathogenesis and evolving treatments. Preliminary evaluations of a novel biotherapeutic strategy are presented here. Twenty OA patients receiving sour topical cherry seed extract (SCE), an inducer of heme oxygenase-1 (HO-1), a major physiological protectant against oxidative stress exhibited significantly decreased joint pain and activation of CD4+ T cells expressing inflammatory cytokines (p < 0.05), significantly decreased peripheral blood C-reactive protein (CRP), and increased leukocyte HO-1 (p < 0.05) in comparison with ten placebo-treated patients. SCE inhibits joint-damaging inflammatory mediator production. This agent therefore meets the main criterion for classification as a "biotherapeutic," or "biologic" agent. The negligible toxicity and low cost of such materials make them promising contributors to OA treatment, sustainable within resource limitations of a wide range of patients.
Insights
Sour topical cherry seed extract (SCE) shows promise for osteoarthritis (OA) treatment by reducing joint pain and inflammation. This biologic agent may offer a low-cost, low-toxicity option for OA management.
Area of Science:
- Biochemistry
- Immunology
- Pharmacology
Background:
- Current osteoarthritis (OA) treatments primarily manage pain without addressing underlying catabolic and anabolic imbalances.
- Biologic drugs, targeting inflammatory mediators, have shown limited efficacy but suggest potential therapeutic strategies for OA.
- Oxidative stress and inflammation are key drivers of OA pathogenesis.
Purpose of the Study:
- To evaluate the efficacy of a novel biotherapeutic strategy using sour topical cherry seed extract (SCE) for osteoarthritis treatment.
- To assess the impact of SCE on joint pain, inflammatory markers, and cellular immune responses in OA patients.
- To determine if SCE qualifies as a biotherapeutic agent based on its mechanism of action and safety profile.
Main Methods:
- A preliminary study involving 20 OA patients treated with topical SCE and 10 patients receiving a placebo.
- Measurement of joint pain, CD4+ T cell activation, C-reactive protein (CRP) levels, and leukocyte heme oxygenase-1 (HO-1) expression.
- Analysis of SCE's effect on inflammatory mediator production.
Main Results:
- Patients treated with SCE reported significantly decreased joint pain compared to the placebo group.
- SCE treatment led to a significant decrease in peripheral blood C-reactive protein (CRP) and activation of CD4+ T cells expressing inflammatory cytokines.
- Leukocyte HO-1 levels were significantly increased in the SCE group, indicating activation of a protective cellular pathway.
- SCE demonstrated inhibition of joint-damaging inflammatory mediator production.
Conclusions:
- Sour topical cherry seed extract (SCE) acts as an inducer of heme oxygenase-1 (HO-1), a key protectant against oxidative stress.
- SCE exhibits potential as a biotherapeutic agent for osteoarthritis by reducing pain and inflammation.
- The negligible toxicity and low cost of SCE make it a promising and sustainable option for OA treatment, accessible to a wide range of patients.
