What side effects are associated with this type of intervention?

Bone Marrow Aspirate Concentrate (BMAC) is generally safe but can cause minor and transient side effects such as pain, bleeding, tenderness, swelling, and bruising at the injection site, with a risk of local infection. Triamcinolone, a corticosteroid, can provide short-term pain relief but may lead to joint infection, post-injection flare, and potential cartilage damage with repeated use. Systemic effects can include elevated blood sugar levels, increased blood pressure, and potential suppression of the immune system.

What prior FDA approvals exist?

The FDA has approved various treatments for hip osteoarthritis, including corticosteroids like Triamcinolone, which are used for their anti-inflammatory properties to provide short-term pain relief. However, there are no specific FDA approvals for Bone Marrow Aspirate Concentrate (BMAC) for hip osteoarthritis, although mesenchymal stem cell therapies are being explored in clinical trials for their regenerative potential. Other approved treatments include nonsteroidal anti-inflammatory drugs (NSAIDs) and hyaluronic acid derivatives, but these do not have the regenerative properties of BMAC.

What other types of research exist?

Promising novel alternatives for hip osteoarthritis treatment in 2024 include: 1) Hyaluronic Acid (HA) formulations such as Hydros and Hydros-TA, which combine HA with triamcinolone acetonide for enhanced joint lubrication and anti-inflammatory effects. 2) Platelet-Rich Plasma (PRP) therapy, which uses autologous platelet concentrates to promote tissue regeneration and reduce inflammation. 3) Low-Level Laser Therapy (LLLT), which has shown potential in improving healing and reducing symptoms in small studies. These alternatives offer a combination of regenerative and anti-inflammatory benefits.

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Stem Cell Therapy

BMAC vs Triamcinolone for Hip Osteoarthritis

Phase 3

Waitlist Available

Led By LEONARDO P OLIVEIRA, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

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

Must have

Unilateral or Bilateral Hip Osteoarthritis

Prior physical therapy treatment for 6 weeks in the last 6 months

Must not have

Prior corticosteroid injection to the hip

History of Diabetes or HbA1c > 6.5%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, infection risk from needle insertion, allergic reactions to components used during the procedure, and general risks associated with bone marrow aspiration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have arthritis in one or both of my hips.

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I have undergone physical therapy for 6 weeks in the past 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a corticosteroid injection in my hip before.

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I have diabetes or my HbA1c level is above 6.5%.

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I am currently taking oral corticosteroids.

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I am currently taking blood thinners.

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I cannot stop taking my oral anti-inflammatory medications.

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I currently have an active infection such as cellulitis, TB, HIV, COVID, or Hepatitis B/C.

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My kidney function is reduced.

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I have not followed recommended cancer screening tests for my age.

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I am unable to give consent for research studies.

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I am taking immunosuppressive medications or have a weakened immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 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

Western Ontario McMaster Universities Arthritis Index (WOMAC)

Secondary study objectives

6 Minute Walk Test (6MWT)

Other study objectives

Global Rate of Change (GRoC)

Pain

PROMIS - Physical Function (PROMIS-PF)

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bone marrow aspirate concentrateExperimental Treatment1 Intervention

Bone marrow that is aspirated then concentrated using a device.

Group II: TriamcinoloneActive Control1 Intervention

Triamcinolone is a corticosteroid.

0 / 12Eligibility criteria met

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

Bone Marrow Aspirate Concentrate (BMAC) leverages the regenerative properties of mesenchymal stem cells (MSCs) to potentially repair and regenerate damaged cartilage in Hip Osteoarthritis (OA) patients, addressing the underlying issue of cartilage degradation. Triamcinolone, an anti-inflammatory corticosteroid, reduces inflammation and pain by inhibiting inflammatory mediators, offering immediate symptomatic relief. These treatments are significant for OA patients as BMAC aims for long-term cartilage repair, while Triamcinolone provides quick pain relief, improving overall quality of life.