Study Summary
This trial is testing whether bone marrow aspirate concentrate (BMAC) is more effective than Triamcinolone in reducing pain and improving function in patients with hip osteoarthritis.
Eligible Conditions
- Hip Osteoarthritis
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Assessing change from Baseline to 6 weeks, 3 months, 6 months, and 12 months
Month 12
6 Minute Walk Test (6WMT)
Global Rate of Change
PROMIS - Pain
PROMIS - Physical Function
Month 12
6 Minute Walk Test (6MWT)
Global Rate of Change (GRoC)
Pain
PROMIS - Physical Function (PROMIS-PF)
Pittsburgh Sleep Quality Index
Western Ontario McMaster Universities Arthritis Index (WOMAC)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Triamcinolone
1 of 2
Bone marrow aspirate concentrate
1 of 2
Active Control
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: Emcyte PureBMC · No Placebo Group · Phase 3
Bone marrow aspirate concentrateExperimental Group · 2 Interventions: Aspire Needle + Emcyte PureBMC, Emcyte PureBMC · Intervention Types: CombinationProduct, CombinationProduct
Triamcinolone
Drug
ActiveComparator Group · 1 Intervention: Triamcinolone · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessing change from baseline to 6 weeks, 3 months, 6 months, and 12 months
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
959 Previous Clinical Trials
1,358,856 Total Patients Enrolled
Lisa Dean Moseley FoundationUNKNOWN
LEONARDO P OLIVEIRA, MDPrincipal InvestigatorCleveland Clinic Florida
Carlos Higuera-Rueda, MDStudy DirectorCleveland Clinic Florida
1 Previous Clinical Trials
160 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · All Participants · 17 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your body mass index (BMI) must be less than 35 kg/m2.
You have hip osteoarthritis in one or both hips.
You have received physical therapy treatment within the last 6 months for a period of 6 weeks or more.
You agree to follow the lifestyle recommendations mentioned in section 5.3.
You have been cancer-free for at least 5 years.
Who else is applying?
What state do they live in?
| Ohio | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Cleveland Clinic Florida | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
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- Centeno, Christopher J., Hasan Al-Sayegh, Michael D. Freeman, Jay Smith, William D. Murrell, and Rostyslav Bubnov. 2016. “A Multi-center Analysis of Adverse Events Among Two Thousand, Three Hundred and Seventy Two Adult Patients Undergoing Adult Autologous Stem Cell Therapy for Orthopaedic Conditions”. International Orthopaedics. Springer Science and Business Media LLC. doi:10.1007/s00264-016-3162-y.
- Kruse, David W.. 2008. “Intraarticular Cortisone Injection for Osteoarthritis of the Hip. Is It Effective? Is It Safe?”. Current Reviews in Musculoskeletal Medicine. Springer Science and Business Media LLC. doi:10.1007/s12178-008-9029-0.
- Hashmi, Shahrukh Khurshid. 2016. “Basics of Hematopoietic Cell Transplantation for Primary Care Physicians and Internists”. Primary Care: Clinics in Office Practice. Elsevier BV. doi:10.1016/j.pop.2016.07.003.
- Kim, Gi Beom, Min-Soo Seo, Wook Tae Park, and Gun Woo Lee. 2020. “Bone Marrow Aspirate Concentrate: Its Uses in Osteoarthritis”. International Journal of Molecular Sciences. MDPI AG. doi:10.3390/ijms21093224.
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- Courties, Alice, and Jérémie Sellam. 2016. “Osteoarthritis and Type 2 Diabetes Mellitus: What Are the Links?”. Diabetes Research and Clinical Practice. Elsevier BV. doi:10.1016/j.diabres.2016.10.021.
- Friedlis, Mayo F., and Christopher J. Centeno. 2016. “Performing a Better Bone Marrow Aspiration”. Physical Medicine and Rehabilitation Clinics of North America. Elsevier BV. doi:10.1016/j.pmr.2016.06.009.
- REZENDE, MÁRCIA UCHÔA DE, HENRIQUE MELO CAMPOS GURGEL, GUILHERME PEREIRA OCAMPOS, GUSTAVO CONSTANTINO DE CAMPOS, RENATO FRUCCHI, ALEXANDRE FELÍCIO PAILO, THIAGO PASQUALIN, JOSÉ RICARDO NEGREIROS VICENTE, and OLAVO PIRES DE CAMARGO. 2020. “Improvements in Hip Osteoarthritis with Lavage, Triamcinolone and Hylan G-F20”. Acta Ortopédica Brasileira. FapUNIFESP (SciELO). doi:10.1590/1413-785220202806240075.
- Lamo-Espinosa, José M., Gonzalo Mora, Juan F. Blanco, Froilán Granero-Moltó, Jorge M. Nuñez-Córdoba, Carmen Sánchez-Echenique, José M. Bondía, et al.. 2016. “Intra-articular Injection of Two Different Doses of Autologous Bone Marrow Mesenchymal Stem Cells Versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis: Multicenter Randomized Controlled Clinical Trial (phase I/II)”. Journal of Translational Medicine. Springer Science and Business Media LLC. doi:10.1186/s12967-016-0998-2.
- Centeno, Christopher J., Hasan Al-Sayegh, Jamil Bashir, Shaun Goodyear, and Michael D. Freeman. 2015. “A Dose Response Analysis of a Specific Bone Marrow Concentrate Treatment Protocol for Knee Osteoarthritis”. BMC Musculoskeletal Disorders. Springer Science and Business Media LLC. doi:10.1186/s12891-015-0714-z.
- Cross, Marita, Emma Smith, Damian Hoy, Sandra Nolte, Ilana Ackerman, Marlene Fransen, Lisa Bridgett, et al.. 2014. “The Global Burden of Hip and Knee Osteoarthritis: Estimates from the Global Burden of Disease 2010 Study”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2013-204763.
- Quinn, Robert H., Jayson Murray, Ryan Pezold, and Quinn Hall. 2018. “Management of Osteoarthritis of the Hip”. Journal of the American Academy of Orthopaedic Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.5435/jaaos-d-18-00351.
- Shapiro, Shane A., Shari E. Kazmerchak, Michael G. Heckman, Abba C. Zubair, and Mary I. O’Connor. 2016. “A Prospective, Single-blind, Placebo-controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546516662455.
- Piuzzi, Nicolas S., Venkata P. Mantripragada, Alan Sumski, Selvaanish Selvam, Cynthia Boehm, and George F. Muschler. 2018. “Bone Marrow-derived Cellular Therapies in Orthopaedics”. JBJS Reviews. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.rvw.18.00007.
- Hootman, Jennifer M., Charles G. Helmick, Kamil E. Barbour, Kristina A. Theis, and Michael A. Boring. 2016. “Updated Projected Prevalence of Self-reported Doctor-diagnosed Arthritis and Arthritis-attributable Activity Limitation Among US Adults, 2015-2040”. Arthritis & Rheumatology. Wiley. doi:10.1002/art.39692.
- Rodriguez‐Fontan, Francisco, Nicolas S. Piuzzi, Matthew J. Kraeutler, and Cecilia Pascual‐Garrido. 2018. “Early Clinical Outcomes of Intra‐articular Injections of Bone Marrow Aspirate Concentrate for the Treatment of Early Osteoarthritis of the Hip and Knee: A Cohort Study”. Pm&r. Wiley. doi:10.1016/j.pmrj.2018.05.016.
- Charlesworth, Jonathon, Jane Fitzpatrick, Nirmala Kanthi Panagodage Perera, and John Orchard. 2019. “Osteoarthritis- a Systematic Review of Long-term Safety Implications for Osteoarthritis of the Knee”. BMC Musculoskeletal Disorders. Springer Science and Business Media LLC. doi:10.1186/s12891-019-2525-0.
- Walters, Mark C.. 2015. “Update of Hematopoietic Cell Transplantation for Sickle Cell Disease”. Current Opinion in Hematology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/moh.0000000000000136.
- Lamo-Espinosa, José M., Gonzalo Mora, Juan F. Blanco, Froilán Granero-Moltó, Jorge M. Nuñez-Córdoba, Carmen Sánchez-Echenique, José M. Bondía, et al.. 2016. “Intra-articular Injection of Two Different Doses of Autologous Bone Marrow Mesenchymal Stem Cells Versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis: Multicenter Randomized Controlled Clinical Trial (phase I/II)”. Journal of Translational Medicine. Springer Science and Business Media LLC. doi:10.1186/s12967-016-0998-2.
- Hootman JM, Helmick CG, Barbour KE, Theis KA, Boring MA. Updated Projected Prevalence of Self-Reported Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation Among US Adults, 2015-2040. Arthritis Rheumatol. 2016 Jul;68(7):1582-7. doi: 10.1002/art.39692.
- Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30. Erratum In: Int Orthop. 2018 Jan;42(1):223.
- Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.
- Friedlis MF, Centeno CJ. Performing a Better Bone Marrow Aspiration. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):919-939. doi: 10.1016/j.pmr.2016.06.009.
- Skwara A, Ponelis R, Tibesku CO, Rosenbaum D, Fuchs-Winkelmann S. Gait patterns after intraarticular treatment of patients with osteoarthritis of the knee--hyaluronan versus triamcinolone: a prospective, randomized, doubleblind, monocentric study. Eur J Med Res. 2009 Apr 16;14(4):157-64. doi: 10.1186/2047-783x-14-4-157.
- Walters MC. Update of hematopoietic cell transplantation for sickle cell disease. Curr Opin Hematol. 2015 May;22(3):227-33. doi: 10.1097/MOH.0000000000000136.
- Piuzzi NS, Mantripragada VP, Sumski A, Selvam S, Boehm C, Muschler GF. Bone Marrow-Derived Cellular Therapies in Orthopaedics: Part I: Recommendations for Bone Marrow Aspiration Technique and Safety. JBJS Rev. 2018 Nov;6(11):e4. doi: 10.2106/JBJS.RVW.18.00007. No abstract available.
- Duclos M. Osteoarthritis, obesity and type 2 diabetes: The weight of waist circumference. Ann Phys Rehabil Med. 2016 Jun;59(3):157-160. doi: 10.1016/j.rehab.2016.04.002. Epub 2016 May 19.
- Hernigou P, Trousselier M, Roubineau F, Bouthors C, Chevallier N, Rouard H, Flouzat-Lachaniette CH. Stem Cell Therapy for the Treatment of Hip Osteonecrosis: A 30-Year Review of Progress. Clin Orthop Surg. 2016 Mar;8(1):1-8. doi: 10.4055/cios.2016.8.1.1. Epub 2016 Feb 13.
- Courties A, Sellam J. Osteoarthritis and type 2 diabetes mellitus: What are the links? Diabetes Res Clin Pract. 2016 Dec;122:198-206. doi: 10.1016/j.diabres.2016.10.021. Epub 2016 Nov 5.
- Hashmi SK. Basics of Hematopoietic Cell Transplantation for Primary Care Physicians and Internists. Prim Care. 2016 Dec;43(4):693-701. doi: 10.1016/j.pop.2016.07.003.
- Kim GB, Seo MS, Park WT, Lee GW. Bone Marrow Aspirate Concentrate: Its Uses in Osteoarthritis. Int J Mol Sci. 2020 May 2;21(9):3224. doi: 10.3390/ijms21093224.
- LEONARDO OLIVEIRA 2023. "Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04990128.
Frequently Asked Questions
What is Emcyte PureBMC's primary purpose?
"Emcyte PureBMC is a versatile treatment that can be used to manage ulcerative colitis, as well as other disorders such as hand, brain, and dermatologic disorders." - Anonymous Online Contributor
Unverified Answer
Could you explain the age range for people who can participate in this experiment?
"This particular trial is seeking patients that fall between 18 and 65 years of age. Out of the 728 similar trials, 41 are for patients younger than 18 and 687 are for patients older than 65." - Anonymous Online Contributor
Unverified Answer
Out of how many people who applied, how many have been selected to participate in this experiment?
"Unfortunately, this particular trial is no longer seeking patients for participation. The trial was originally posted on 1/10/2023 and last edited on 10/16/2022. However, there are 678 other trials for hip joint patients and 47 trials for Emcyte PureBMC patients that are still looking for participants." - Anonymous Online Contributor
Unverified Answer
What are the risks associated with using Emcyte PureBMC?
"Emcyte PureBMC has been evaluated for safety and given a 3. This is based on it being a Phase 3 trial, which means that there is both efficacy data and multiple rounds of safety data available." - Anonymous Online Contributor
Unverified Answer
What is the general efficacy of Emcyte PureBMC in a clinical setting?
"At the moment, there are 47 clinical trials underway that are looking into Emcyte PureBMC. 8 of those studies are in the third and final phase. The majority of trials for Emcyte PureBMC are taking place in Columbia, Missouri, but there are a total of 80 locations running trials for this potential treatment." - Anonymous Online Contributor
Unverified Answer
Who does this trial's screening process accept?
"This trial is looking for 100 participants who currently have hip joint pain and meet the following criteria:-Willingness to comply with all study procedures and availability for the duration of the study-Agreement to adhere to Lifestyle Considerations-Provision of signed and dated consent form-Male or female, aged between 18 - 65 years old-WOMAC ≥ 50-Kellgren-Lawrence Grade 2 or higher on Hip X-Rays-Body Mass Index < 35 kg/m2-Unilateral or Bilateral Hip Osteoarthritis-Prior physical" - Anonymous Online Contributor
Unverified Answer
Are patient volunteers currently being enrolled in this experiment?
"No, this particular study is no longer looking for participants. It was first posted on January 10th, 2023 but the most recent update was on October 16th, 2022. Although this trial has completed recruitment, there are 725 other clinical trials that are still looking for patients." - Anonymous Online Contributor
Unverified Answer