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Aspire Needle+ Emcyte PureBMC

Phase 3

Hip Osteoarthritis | Small molecule | Musculoskeletal |Community Health Systems, Inc.|Last Updated: Aug 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Aspire Needle+ Emcyte PureBMC · 1 trial · 1 indication

Phase 3 1
NCT04990128Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip OsteoarthritisHip Osteoarthritis
NOT YET_RECRUITING100 Analytics
PHASE3NOT YET_RECRUITING
Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis
Hip OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Western Ontario McMaster Universities Arthritis Index (WOMAC)
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.

WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Secondary Endpoints

6 Minute Walk Test (6MWT)
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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bone marrow aspirate concentrateEXPERIMENTALBone marrow that is aspirated then concentrated using a device.
TriamcinoloneACTIVE_COMPARATORTriamcinolone is a corticosteroid.

Interventions

NameTypeDescription
Aspire Needle + Emcyte PureBMCCOMBINATION_PRODUCTThe 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.
TriamcinoloneDRUG40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 2...

Countries:United States
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