Clinical Trial Evaluates Bone Marrow Aspirate Concentrate for Hip Osteoarthritis

Bone marrow aspirate concentrate (BMAC) is an emerging orthobiologic that has shown promise for the treatment of early osteoarthritis (OA). To contribute to the greater understanding of this new treatment modality, Cleveland Clinic researchers in Florida have launched the first ever phase III clinical trial to research the effects of BMAC versus triamcinolone in patients with hip OA.

“Several clinical studies have demonstrated improved pain management and joint function after BMAC treatment in knee osteoarthritis, but there is very little data on hip OA and currently no randomized controlled trials,” explains principal investigator Leonardo Oliveira, MD, a sports medicine physician at Cleveland Clinic Weston Hospital and the Coral Springs Family Health and Surgery Center who specializes in joint preservation treatments.

Addressing an unmet need in hip OA treatment

Treatment goals for hip OA are to minimize pain and improve joint function and physical activity. Initial management typically includes weight loss, rehabilitation, activity modification, assistive devices, anti-inflammatory medications and nutritional supplements.

For patients who need additional relief before considering surgery, injection therapies such as corticosteroids are another option. However, repeated corticosteroid injections may have limitations.

“In my own clinical experience, I’ve seen a diminished response in patients receiving repeated corticosteroid injections, and the latest research suggests the long-term use of steroids may accelerate joint deterioration,” says Dr. Oliveira. “There is clearly a need for safer, more efficacious treatment alternatives than what is currently available.”

Orthobiologics, including platelet-rich plasma and BMAC, are gaining attention among orthopaedic specialists seeking new approaches to managing OA symptoms and supporting tissue function in the setting of cartilage injuries or joint damage.

BMAC contains mesenchymal stem cells (MSCs) along with growth factors and cytokines. These cellular and signaling components have potential regenerative, anabolic and anti-inflammatory properties that make BMAC an area of interest for OA treatment. The clinical evidence, however, remains limited but promising, particularly for hip OA.

Evidence points to potential, but critical questions remain

In a narrative review coauthored by Dr. Oliveira that examined studies of MSC injections for hip OA, five of the six studies included reported statistically significant improvement in at least one patient-reported outcome score. None reported major complications.

The findings suggest potential for symptom relief, but the studies were small and varied in their approaches and follow-up periods.

“Large randomized controlled trials are needed to establish clinical efficacy,” says Dr. Oliveira. “Standardized characterization and reporting of the cellular components of these orthobiologics are also important to advance the field and help inform future treatment protocols.”

The new trial underway at Weston Hospital is designed to address both needs by comparing clinical outcomes after BMAC and corticosteroid injections while also characterizing the cellular composition of the BMAC administered.

Comparing BMAC with corticosteroid injection

The single-site, randomized controlled study will enroll 100 patients, with 50 randomized to each treatment arm. Eligible participants will have symptomatic unilateral or bilateral hip OA and will have completed conservative treatment, including six weeks of physical therapy within the past 12 months, along with compliance with a home exercise program.

Patients assigned to the BMAC arm will undergo bone marrow aspiration from the posterior superior iliac spine. The aspirate will be concentrated at the point of care using a commercial kit. Before intra-articular injection, researchers will assess BMAC viability, bacterial presence, volume and total nucleated cell counts.

Patients assigned to the triamcinolone arm will undergo a sham bone marrow aspiration at the same location to simulate the procedure and maintain participant blinding. Both groups will receive ultrasound-guided hip injections.

Researchers will measure changes in pain and function from baseline through 12 months after treatment using validated patient-reported outcome measures, including the Western Ontario and McMaster Universities Arthritis Index (WOMAC). They will also assess functional performance using the six-minute walk test.

The study will help determine whether BMAC provides meaningful improvements in pain and function compared with corticosteroid injection and how treatment responses evolve over time.

“Based on past patient experience, we believe the triamcinolone will generate earlier, short term pain relief while BMAC will take longer to have an effect but with a longer duration,” says Dr. Oliveira.

Characterizing BMAC to inform future treatment standards

The research team will also examine the relationship between the cellular characteristics of BMAC and patient reported outcomes. Samples will undergo flow cytometry to detect mesenchymal stem cells and cell analysis to assess colony-forming units. By correlating these laboratory findings with clinical outcomes, researchers aim to better understand whether the cellular composition of an injection is associated with treatment response.

“BMAC carries a concentration of mesenchymal stem cells, growth factors and cytokines that are involved in angiogenesis, chondrocyte metabolism, stem cell homing, and anti-inflammatory response,” explains Dr. Oliveira. “To confirm clinical efficacy of BMAC and help establish treatment standards in the future, including optimal dosage, we need to verify the concentration and potency of the cellular elements in the injection samples.”

Dr. Oliveira points to philanthropy’s vital role in investigating alternative treatment approaches like BMAC. “Our study is funded in part by the Lisa Dean Moseley Foundation, and we are deeply grateful for their support,” he adds.

Complete patient inclusion and exclusion criteria are available online. To refer a patient for study participation, please contact research coordinator Zoe Healy at (954) 659-6152 or healyz@ccf.org.