Recruiting
Phase 3

BMAC vs. Triamcinolone

Sponsor:

The Cleveland Clinic

Code:

NCT04990128

Conditions

Hip Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Aspire Needle + Emcyte PureBMC

Triamcinolone

Study Details

Brief summary:

This is a single site, randomized single blinded, two arm study researching the effects of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in patients with hip osteoarthritis. The aims and hypothesis are as follows:

Specific Aim 1: 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 (6 weeks, 3 months, 6 months, and 12 months).

Hypothesis: The investigators hypothesize that triamcinolone and BMAC groups will have pain reduction after each respective intervention. The changes with triamcinolone will be noticeable on the short term. The BMAC changes will take longer to have an effect but will longer duration. The investigators hypothesize that at 6 months and 1 year participants receiving BMAC will have better scores reported on the WOMAC compared to the triamcinolone injection and better than prior to injection.

Specific Aim 2: Evaluate the change of bone marrow aspirate injection in comparison to triamcinolone in participant's performance on the 6 minute walk test from baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months).

Hypothesis: The investigators hypothesize that there will be higher walking distances on the 6 minute walk test in the participants receiving a BMAC injection in comparison to triamcinolone starting at the 3 months follow-up time.

Specific Aim 3: Quantify and correlate cell characterization with patient reported outcomes score.

Hypothesis: The investigators hypothesize that there will be better patient reported outcomes in patients who have a higher concentration of mesenchymal stem cells injected.

The investigators will enroll 50 patients into each arm. Bone marrow will be aspirated then subsequently concentrated using the Emcyte PureBMC kit. The investigators will test the BMAC viability, rapid sterility, platelet concentration, volume, and total nucleated cell counts prior to injecting. The BMAC will be utilized as a hip injection into the affected hip of the patient.

Patients receiving the Triamcinolone will undergo a sham bone needling to simulate the aspiration to keep patients blinded. Both groups will receive their injections under ultrasound guidance.

Conditions

Hip Osteoarthritis

Study ID

NCT04990128

Start date

Aug 28, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion:

1. Provision of signed and dated consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged between 18 - 75 years old
4. WOMAC Pain Subscale Total Score of 5 or higher in the Likert Scale (total score is 20)
5. Kellgren-Lawrence Grade ≥ 2 on Hip X-Rays
6. Body Mass Index ≤ 35 kg/m\^2
7. Unilateral or Bilateral Hip Osteoarthritis
8. Prior physical therapy treatment for 6 weeks in the last 12 months and compliance with home exercise program
9. Agreement to adhere to Lifestyle Considerations
10. Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements
11. Patients with cancer in remission for at least 5 years. Specific cancers which were treated with surgical resection and are not undergoing chemotherapy/radiation therapy such as breast cancer, colon cancer, or skin cancer, and others could participate when deemed in remission for 1 year. Written approval from oncologist will be necessary prior to enrollment
12. Negative gram stain result

Exclusion:

1. Prior corticosteroid injection to the hip
2. History of hip replacement(s)
3. Noncompliance to preventive screening tests for cancer indicated by age
4. Active autoimmune disease
5. Current use of oral corticosteroid
6. Use of immunosuppressive medications, or who are known to me immunocompromised
7. Inability to be weaned of oral anti-inflammatory medications
8. History of Diabetes or HbA1c ≥ 6.5%
9. Uncontrolled Thyroid Dysfunction: 0.450 uIU/mL ≥ TSH levels ≥ 4.500 uIU/mL
10. Vitamin D Level < 30 ng/ml
11. Anemia (Hgb < 11.7 g/dL for Women; Hgb < 13 g/dL for men)
12. eGFR < 60 mL/min/1.73 m\^2
13. Thrombocytopenia with platelet count less than 150,000 x 10\^9 L
14. Patients with coagulopathies based on known clotting disorder
15. Patients currently on anti-coagulation therapies
16. Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C
17. Moving over the next year
18. Inability to consent to the research study
19. Inability to complete forms electronically
20. Subjects in any other clinical trials
21. History of allergic reaction to lidocaine
22. Pregnancy or planning to be pregnant during trial
23. Breastfeeding

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bone marrow aspirate concentrate

Bone marrow that is aspirated then concentrated using a device.

active comparator: Triamcinolone

Triamcinolone is a corticosteroid.

Interventions

Aspire Needle + Emcyte PureBMC

The Aspire Needle will be utilized to extract the bone marrow and the Emcyte PureBMC will be used to concentrate bone marrow aspirate. The final concentrate will be injected into the hip.

Triamcinolone

40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.

Primary outcome measure

  • Western Ontario McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 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 6 weeks. ]
  • Western Ontario McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 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 3 months. ]
  • Western Ontario McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 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 6 months. ]
  • Western Ontario McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

LEONARDO P OLIVEIRA, MD

(954)659-5430oliveil@ccf.org

Zoe Healy, MS

(954)659-6152Healyz@ccf.org

Locations

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

Leonardo Oliveira, MD

(954) 659-5430oliveil@ccf.org

Zoe Healy, MS

(954) 659-6152Healyz@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • bone marrow aspirate concentrate
  • triamcinolone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-09-09.