What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly those focusing on cartilage regeneration, include NSAIDs, intraarticular glucocorticoid injections, and investigational approaches like platelet-rich plasma (PRP) and tissue gene therapy. NSAIDs can cause gastrointestinal, cardiovascular, and renal side effects. Intraarticular glucocorticoid injections may lead to joint infection, cartilage damage, and systemic effects if used frequently. PRP injections generally have minor and transient side effects such as pain, bleeding, tenderness, and swelling at the injection site. Tissue gene therapy, while still under investigation, has shown some promise but may carry risks associated with gene therapy, including immune reactions and potential long-term effects that are not yet fully understood.

What prior FDA approvals exist?

There is limited information available regarding specific FDA approvals for cartilage-regenerating treatments for osteoarthritis. Traditional treatments for osteoarthritis include NSAIDs, intraarticular glucocorticoids, and physical therapy. Investigational approaches such as platelet-rich plasma (PRP) and mesenchymal stem cell therapy have shown promise in clinical trials for cartilage regeneration, but more large-scale studies are needed to confirm their efficacy and safety. As of now, these regenerative treatments are not yet standard practice and are still under investigation.

What other types of research exist?

Promising novel alternatives to RHH646 for osteoarthritis treatment include: 1) Combination of MEK-ERK inhibitor U0126 with hyaluronic acid (HA), which has shown synergistic effects on anti-hypertrophic and pro-chondrogenic activities. 2) Intra-articular injection of AOD9604, especially when combined with HA, which has demonstrated enhanced cartilage regeneration in preclinical models. 3) Intra-articular injection of sprifermin (rhFGF-18), which has shown an increase in femorotibial cartilage depth in clinical trials, although its long-term clinical relevance is still under investigation.

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Regenerative Medicine

RHH646 for Knee Osteoarthritis

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment until study completion (approximately 14 months)

Summary

This trial is testing RHH646, a treatment aimed at repairing knee cartilage. It targets people with knee osteoarthritis, a condition where knee cartilage wears down. The treatment helps rebuild this cartilage, potentially reducing pain and improving movement.

Who is the study for?

This trial is for adults aged 35-75 with knee osteoarthritis, meeting specific criteria like weight over 50 kg, BMI ≤35 kg/m2, and certain levels of joint space width. They must have regular knee pain relieved by analgesics. Excluded are pregnant women not using contraception, those with recent or planned surgeries on the target knee, severe malalignment in the knee, other major knee pathologies or conditions affecting MRI procedures.

What is being tested?

The study tests RHH646's ability to regenerate cartilage in the knee against a placebo in participants with osteoarthritis. The treatment lasts up to one year and aims to assess both safety and effectiveness.

What are the potential side effects?

While specific side effects aren't listed here, common ones for treatments like RHH646 could include injection site reactions, gastrointestinal issues (like nausea), headaches, dizziness or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment until study completion (approximately 14 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment until study completion (approximately 14 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until study completion (approximately 14 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in cartilage volume in the index region of the target knee by magnetic resonance imaging at Week 52

Number of participants with Adverse Events

Secondary study objectives

RHH646 plasma concentrations

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RHH646Experimental Treatment1 Intervention

RHH646

Group II: PlaceboPlacebo Group1 Intervention

RHH646 placebo

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) include NSAIDs, glucocorticoids, and investigational agents like BMP-7 and FGF-18. NSAIDs and glucocorticoids primarily provide symptomatic relief by reducing inflammation and pain but do not alter disease progression. In contrast, investigational treatments like BMP-7 and FGF-18 focus on cartilage regeneration. BMP-7 promotes tissue repair and suppresses catabolic cytokines, while FGF-18 stimulates cartilage matrix formation. These regenerative approaches are crucial for OA patients as they aim to restore cartilage health and potentially slow or reverse disease progression, addressing the underlying joint damage rather than just alleviating symptoms.