BMAC vs Triamcinolone for Hip Osteoarthritis

Overseen By Zoe Healy, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: The Cleveland Clinic

Must not be taking: Oral corticosteroids, Immunosuppressives

Disqualifiers: Diabetes, Autoimmune disease, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two treatments for hip osteoarthritis: bone marrow aspirate concentrate (BMAC) and Triamcinolone. The goal is to determine which treatment more effectively reduces pain and improves walking ability over time. Participants will receive either a BMAC or Triamcinolone injection, and researchers will compare their pain levels and walking distances over a year. The trial seeks individuals with hip osteoarthritis who have undergone physical therapy in the last six months and are willing to stop using pain medications two weeks before the trial begins. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatments.

Will I have to stop taking my current medications?

Yes, you will need to stop taking pain and anti-inflammatory medications two weeks before the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bone marrow aspirate concentrate (BMAC) is generally safe for individuals with osteoarthritis. One study found that BMAC improved patients' perceptions of their knee osteoarthritis over a year, suggesting it might also be safe and beneficial for hip osteoarthritis. Before using BMAC, researchers ensure it is clean and verify the cell count.

Triamcinolone, a steroid used to reduce swelling, has been widely used for many conditions, providing extensive knowledge about its safety. It is usually well-tolerated, though some individuals might experience short-term side effects like elevated blood sugar or mood changes.

Both treatments have demonstrated potential benefits and are being carefully studied to ensure safety for individuals with hip osteoarthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for hip osteoarthritis, which often include pain medications and physical therapy, bone marrow aspirate concentrate (BMAC) offers a unique approach. BMAC is derived from a patient's own bone marrow and concentrated to enhance its regenerative properties, potentially promoting more natural healing of joint tissues. Researchers are excited about BMAC because it targets the underlying causes of joint degeneration rather than just alleviating symptoms. By using the body's own cells, it may offer a more sustainable solution to pain and mobility issues associated with hip osteoarthritis.

What evidence suggests that this trial's treatments could be effective for hip osteoarthritis?

This trial will compare the effectiveness of bone marrow aspirate concentrate (BMAC) and Triamcinolone for hip osteoarthritis. Research has shown that BMAC can help people with osteoarthritis by reducing pain and improving movement, with benefits lasting at least a year. It may work by containing cells that help heal tissues and reduce swelling. Triamcinolone, another treatment option in this trial, is a type of steroid known to quickly reduce pain, though its effects might not last as long as those of BMAC. Both treatments effectively relieve pain, but BMAC might offer longer-lasting results. ^{1 2 6 7 8}

Who Is on the Research Team?

Carlos Higuera-Rueda, MD

Principal Investigator

Cleveland Clinic Florida

Leonardo Oliveira, MD

Principal Investigator

Cleveland Clinic Florida

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-65 with hip osteoarthritis, who have had physical therapy but no recent corticosteroid injections or active autoimmune diseases. Participants must not be pregnant, planning pregnancy, or have a history of certain medical conditions like uncontrolled diabetes or thyroid dysfunction.

Inclusion Criteria

WOMAC Pain Subscale With Average Score(Total WOMAC Pain Score Divided by 5) Equal to 4 or higher

Kellgren-Lawrence Grade > 2 on Hip X-Rays

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Inability to complete forms electronically

Active autoimmune disease

History of hip replacement(s)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a bone marrow aspirate concentrate (BMAC) injection or a triamcinolone injection under ultrasound guidance

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness at 6 weeks post-procedure

6 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for changes in pain and functional scores at 3 months, 6 months, and 12 months post-procedure

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Emcyte PureBMC
• Triamcinolone

Trial Overview

The study compares the effectiveness of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in reducing pain and improving function in hip osteoarthritis patients. It measures outcomes through patient-reported scores and performance on a walking test over 12 months.

How Is the Trial Designed?

Group I: Bone marrow aspirate concentrate Experimental Treatment 1 Intervention

Bone marrow that is aspirated then concentrated using a device.

Group II: Triamcinolone Active Control 1 Intervention

Triamcinolone is a corticosteroid.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Lisa Dean Moseley Foundation

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

In a study involving 30 patients with hip osteoarthritis, the extended-release formulation of triamcinolone acetonide (TA-ER) was found to have a comparable safety profile to the conventional crystalline suspension (TAcs), with fewer treatment-emergent adverse events (TEAEs) reported (26.7% for TA-ER vs. 46.7% for TAcs).

TA-ER resulted in significantly lower peak plasma concentrations and overall systemic exposure compared to TAcs, suggesting a potentially safer profile with gradual elimination from the body, which may reduce the risk of systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Open-Label, Single-Dose Study to Assess Safety and Systemic Exposure of Triamcinolone Acetonide Extended-Release in Patients With Hip Osteoarthritis. Kivitz, A., Mehra, P., Hanson, P., et al.[2022]

In a phase 2 study involving 25 patients with shoulder osteoarthritis, triamcinolone acetonide extended-release (TA-ER) demonstrated a lower systemic exposure compared to the crystalline suspension (TAcs), suggesting a potentially improved safety profile for TA-ER.

Both formulations were well-tolerated, with no serious adverse events reported, indicating that TA-ER may provide effective treatment with reduced risk of systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study. Hanson, P., Kivitz, A., Mehra, P., et al.[2023]

In a study of 60 osteoarthritis patients receiving intra-articular injections, triamcinolone hexacetonide combined with lidocaine significantly reduced joint swelling and decreased the need for pain relief medication over 48 weeks.

However, the treatment did not show any impact on the radiographic progression of osteoarthritis in the injected joints, indicating that while it helps with symptoms, it does not alter the underlying disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide injections in hands osteoarthritis ‒ A double-blinded randomized controlled trial with a one year follow-up. Paschoal, NOS., Natour, J., Machado, FS., et al.[2022]

Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving stiffness and physical function, demonstrating its efficacy as a treatment option.

The formulation of triamcinolone acetonide ER in PLGA microspheres allows for prolonged release in the joint, minimizing systemic exposure and related side effects, making it a safer alternative to traditional corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Paik, J., Duggan, ST., Keam, SJ.[2023]

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PureBMC SP

A cutting-edge bone marrow concentrating system engineered to deliver superior BMC formulations enriched with the highest concentrations of hematopoietic stem ...