BMAC vs Triamcinolone for Hip Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen byLeonardo Oliveira, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: The Cleveland Clinic

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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

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Exclusion Criteria

Inability to complete forms electronically

Active autoimmune disease

History of hip replacement(s)

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Treatment Details

Interventions

Emcyte PureBMC (Stem Cell Therapy)
Triamcinolone (Corticosteroid)

Trial OverviewThe 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

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.