What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs, intra-articular corticosteroids, and platelet-rich plasma (PRP), have various side effects. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and renal problems. Intra-articular corticosteroids may lead to joint infection, post-injection flare, and potential cartilage damage with repeated use. PRP injections generally have minor and transient side effects like pain, bleeding, tenderness, swelling, and bruising at the injection site, with a risk of local infection. These treatments aim to reduce inflammation and promote tissue repair but come with their respective risks.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis that focus on reducing inflammation and promoting tissue repair. Notably, platelet-rich plasma (PRP) has been used to treat musculoskeletal conditions, including osteoarthritis, by providing high concentrations of growth factors to reduce inflammation and promote tissue repair. Anti-NGF agents like tanezumab have shown efficacy in reducing pain and improving function, although they have faced safety concerns. While BMAC is still under investigation, these treatments share a similar goal of addressing the underlying inflammatory and degenerative processes in osteoarthritis.

What other types of research exist?

Promising novel alternatives to Bone Marrow Aspirate Concentrate (BMAC) for osteoarthritis treatment include: 1) Adipose-derived mesenchymal stem cells (ADMSCs), which have shown potential in promoting tissue repair and reducing inflammation. 2) Platelet-rich plasma (PRP) therapy, which utilizes concentrated platelets to enhance healing and reduce inflammation. 3) Hyaluronic acid-based scaffolds combined with activated stem cells, which have demonstrated better clinical outcomes and durable cartilage repair in medium-term follow-ups. These alternatives are being actively researched and may offer effective treatment options for osteoarthritis patients in 2024.

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BMAC vs Corticosteroids for Osteoarthritis (BMAC Trial)

N/A

Recruiting

Led By Jorge Chahla, MD

Research Sponsored by Rush University Medical Center

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 enrollment up to 6 months postoperatively (12 months if crossover from arm 3 to arm 1)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if BMAC injections can improve symptoms in patients with knee osteoarthritis by helping repair knee tissues and reduce inflammation. It compares BMAC to standard corticosteroid injections over several months. Bone Marrow Aspirate Concentrate (BMAC) has been studied as a regenerative therapy for knee osteoarthritis, showing promise in improving pain and functionality.

Who is the study for?

This trial is for adults aged 18-70 with moderate knee osteoarthritis pain (KL grade 2-3) that persists despite treatments like exercise, weight loss, or painkillers. They must have a pain score of at least 4 and not have had recent knee injections. Those with post-traumatic arthritis, diabetes, cancer, infections or other systemic diseases cannot participate.

What is being tested?

The study compares the effects of corticosteroid injections versus bone marrow aspirate concentrate (BMAC), which is derived from the patient's own bone marrow. Participants are randomly assigned to one treatment and their reported outcomes are tracked over time.

What are the potential side effects?

Corticosteroid injections may cause joint infection, nerve damage, thinning of nearby bone or soft tissue and temporary flare of joint pain. BMAC side effects could include pain at the extraction site but generally has fewer risks as it uses the patient's own cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment up to 6 months postoperatively (12 months if crossover from arm 3 to arm 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment up to 6 months postoperatively (12 months if crossover from arm 3 to arm 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment up to 6 months postoperatively (12 months if crossover from arm 3 to arm 1) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Intermittent and Constant Osteoarthritis Pain (ICOAP)

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Visual analogue scale (VAS) for pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Crossover GroupExperimental Treatment1 Intervention

Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3).

Group II: Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injectionsExperimental Treatment1 Intervention

Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. "Autologous" means that the subject is receiving back their own cells that were collected.

Group III: Corticosteroid injectionActive Control1 Intervention

Corticosteroid injection group (ARM 2) will receive a sham incision.

Do I qualify?Apply below to find out

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) focus on pain relief and reducing inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen reduce inflammation by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the inflammatory process. Corticosteroids, such as prednisone, reduce inflammation by suppressing the immune response. Emerging treatments like Bone Marrow Aspirate Concentrate (BMAC) and Platelet-Rich Plasma (PRP) aim to promote tissue repair and reduce inflammation by delivering high concentrations of growth factors that enhance cell proliferation and matrix synthesis. These treatments are significant for OA patients as they not only provide symptomatic relief but also have the potential to improve joint function and slow disease progression.

Prevalence, Impact, and Treatment of Co-Occurring Osteoarthritis in Patients With Stroke Undergoing Rehabilitation: A Review.Primary care treatment of knee pain--a survey in older adults.