BMAC vs Triamcinolone for Hip Osteoarthritis

Overseen By Jillian King, BSc

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

100 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug triamcinolone acetonide for hip osteoarthritis?

Triamcinolone acetonide, a type of corticosteroid, is recommended for treating hip osteoarthritis and has been shown to help reduce pain and inflammation in the joint. ^{1 2 3 4 5}

Is Triamcinolone safe for treating osteoarthritis?

Triamcinolone acetonide, used in various forms for osteoarthritis, is generally well tolerated with a safety profile similar to placebo and other forms of triamcinolone. It is designed to reduce systemic exposure, which helps lessen common steroid-related side effects like blood sugar increases. ^{1 2 3 6 7}

How does the drug triamcinolone acetonide differ from other treatments for hip osteoarthritis?

Triamcinolone acetonide is a corticosteroid that can be injected directly into the hip joint to reduce inflammation and pain, offering a targeted approach compared to oral medications. The extended-release form provides longer-lasting relief, which may reduce the frequency of injections needed. ^{1 2 3 6 8}

What is the purpose of this trial?

This trial compares two treatments for hip osteoarthritis: one that uses the patient's own bone marrow cells to promote healing, and another that uses a steroid to quickly reduce inflammation. The study aims to determine which treatment offers better long-term pain relief and improved mobility.

Research Team

Carlos Higuera-Rueda, MD

Principal Investigator

Cleveland Clinic Florida

Leonardo Oliveira, MD

Principal Investigator

Cleveland Clinic Florida

Eligibility Criteria

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

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

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

Exclusion Criteria

Inability to complete forms electronically

Active autoimmune disease

History of hip replacement(s)

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. England 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. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. [2022]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Rapid Onset of Femoral Head Osteonecrosis After a Single Intra-articular Hip Joint Injection of Corticosteroid. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Intra-articular injection of triamcinolone acetonide sustains macrophage levels and aggravates osteophytosis during degenerative joint disease in mice. [2022]

6. New Zealand 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. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. [2023]

8. Norway pubmed.ncbi.nlm.nih.gov

Clinical comparison of triamcinolonehexacetonide and betamethasone in the treatment of osteoarthrosis of the knee-joint. [2015]