Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2022-08-16
2023-08-16
Brief Summary
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* Will the hip or the arm have more bone marrow extracted?
* Does a patient lying in lateral decubitus position produce more bone marrow than lying in the prone position?
Participants that are to undergo rotator-cuff repair are eligible for this study. During the participant's repair, bone marrow will be extracted from the arm and from the hip. Half of the eligible participants will have bone marrow extracted from the hip while lying on their side, while the other half will have bone marrow extracted from the hip while lying on their back. Researchers will compare the results from both extraction sites on each patient, as well as compare results of the two patient position groups.
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Detailed Description
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After the described screening and informed consent process have been completed, all participants will undergo standard-of-care arthroscopic rotator cuff repair surgery. During all surgeries, bone marrow will be aspirated from the PSIS and from the humerus. The first 15 participants will have bone marrow aspirated from the PSIS while in the prone position on the operating table. The final 15 participants will have bone marrow aspirated from the PSIS while in the lateral decubitus position on the operating table. Both cohorts will undergo humeral harvest intraoperatively in the lateral decubitus position. One mL of concentrated bone marrow aspirate (cBMA) from each harvest site from each surgery will be removed and sent to the AREF Regenerative Medicine Center (RMC) for analysis. The remaining cBMA will be used to augment the rotator cuff repair surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bone marrow harvest from side-lying patient
This group will have bone marrow harvested from the PSIS extraction site while lying in the lateral decubitus position.
Rotator Cuff Repair
Surgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor)
Bone Marrow Harvest
Procedure in which bone marrow cells are extracted, or harvested, from a given location in the body
Bone marrow harvest from patient lying prone
This group will have bone marrow harvested from the PSIS extraction site while lying in the prone position.
Rotator Cuff Repair
Surgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor)
Bone Marrow Harvest
Procedure in which bone marrow cells are extracted, or harvested, from a given location in the body
Interventions
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Rotator Cuff Repair
Surgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor)
Bone Marrow Harvest
Procedure in which bone marrow cells are extracted, or harvested, from a given location in the body
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of a rotator cuff tear requiring arthroscopic rotator cuff repair
Exclusion Criteria
* Diabetes
* Immune Disorders
* Past medical history of a metastatic or other cancer which required chemotherapy/ radiation therapy
* Rheumatoid arthritis
* Is unable to comprehend the study documents or give informed consent
18 Years
80 Years
ALL
No
Sponsors
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Florida
OTHER
Andrews Research & Education Foundation
OTHER
Responsible Party
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Principal Investigators
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Joshua Hackel, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopedic Surgeon
Locations
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Andrews Research and Education Foundation
Gulf Breeze, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Akpancar S, Tatar O, Turgut H, Akyildiz F, Ekinci S. The Current Perspectives of Stem Cell Therapy in Orthopedic Surgery. Arch Trauma Res. 2016 Aug 16;5(4):e37976. doi: 10.5812/atr.37976. eCollection 2016 Dec.
Marycz K, Mierzejewska K, Smieszek A, Suszynska E, Malicka I, Kucia M, Ratajczak MZ. Endurance Exercise Mobilizes Developmentally Early Stem Cells into Peripheral Blood and Increases Their Number in Bone Marrow: Implications for Tissue Regeneration. Stem Cells Int. 2016;2016:5756901. doi: 10.1155/2016/5756901. Epub 2015 Nov 9.
Rochefort GY, Delorme B, Lopez A, Herault O, Bonnet P, Charbord P, Eder V, Domenech J. Multipotential mesenchymal stem cells are mobilized into peripheral blood by hypoxia. Stem Cells. 2006 Oct;24(10):2202-8. doi: 10.1634/stemcells.2006-0164. Epub 2006 Jun 15.
Hauser RA, Orlofsky A. Regenerative injection therapy with whole bone marrow aspirate for degenerative joint disease: a case series. Clin Med Insights Arthritis Musculoskelet Disord. 2013 Sep 4;6:65-72. doi: 10.4137/CMAMD.S10951. eCollection 2013.
Hernigou P, Flouzat Lachaniette CH, Delambre J, Zilber S, Duffiet P, Chevallier N, Rouard H. Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop. 2014 Sep;38(9):1811-8. doi: 10.1007/s00264-014-2391-1. Epub 2014 Jun 7.
Hernigou P, Poignard A, Zilber S, Rouard H. Cell therapy of hip osteonecrosis with autologous bone marrow grafting. Indian J Orthop. 2009 Jan;43(1):40-5. doi: 10.4103/0019-5413.45322.
Hernigou P, Poignard A, Beaujean F, Rouard H. Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005 Jul;87(7):1430-7. doi: 10.2106/JBJS.D.02215.
Saw KY, Anz A, Siew-Yoke Jee C, Merican S, Ching-Soong Ng R, Roohi SA, Ragavanaidu K. Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial. Arthroscopy. 2013 Apr;29(4):684-94. doi: 10.1016/j.arthro.2012.12.008. Epub 2013 Feb 4.
Vangsness CT Jr, Sternberg H, Harris L. Umbilical Cord Tissue Offers the Greatest Number of Harvestable Mesenchymal Stem Cells for Research and Clinical Application: A Literature Review of Different Harvest Sites. Arthroscopy. 2015 Sep;31(9):1836-43. doi: 10.1016/j.arthro.2015.03.014.
Kitoh H, Kitakoji T, Tsuchiya H, Katoh M, Ishiguro N. Transplantation of culture expanded bone marrow cells and platelet rich plasma in distraction osteogenesis of the long bones. Bone. 2007 Feb;40(2):522-8. doi: 10.1016/j.bone.2006.09.019. Epub 2006 Oct 27.
Ellera Gomes JL, da Silva RC, Silla LM, Abreu MR, Pellanda R. Conventional rotator cuff repair complemented by the aid of mononuclear autologous stem cells. Knee Surg Sports Traumatol Arthrosc. 2012 Feb;20(2):373-7. doi: 10.1007/s00167-011-1607-9. Epub 2011 Jul 20.
Hyer CF, Berlet GC, Bussewitz BW, Hankins T, Ziegler HL, Philbin TM. Quantitative assessment of the yield of osteoblastic connective tissue progenitors in bone marrow aspirate from the iliac crest, tibia, and calcaneus. J Bone Joint Surg Am. 2013 Jul 17;95(14):1312-6. doi: 10.2106/JBJS.L.01529.
Pierini M, Di Bella C, Dozza B, Frisoni T, Martella E, Bellotti C, Remondini D, Lucarelli E, Giannini S, Donati D. The posterior iliac crest outperforms the anterior iliac crest when obtaining mesenchymal stem cells from bone marrow. J Bone Joint Surg Am. 2013 Jun 19;95(12):1101-7. doi: 10.2106/JBJS.L.00429.
Beitzel K, McCarthy MB, Cote MP, Durant TJ, Chowaniec DM, Solovyova O, Russell RP, Arciero RA, Mazzocca AD. Comparison of mesenchymal stem cells (osteoprogenitors) harvested from proximal humerus and distal femur during arthroscopic surgery. Arthroscopy. 2013 Feb;29(2):301-8. doi: 10.1016/j.arthro.2012.08.021. Epub 2013 Jan 3.
Marx RE, Tursun R. A qualitative and quantitative analysis of autologous human multipotent adult stem cells derived from three anatomic areas by marrow aspiration: tibia, anterior ilium, and posterior ilium. Int J Oral Maxillofac Implants. 2013 Sep-Oct;28(5):e290-4. doi: 10.11607/jomi.te10.
Vasiliadis AV, Galanis N. Human bone marrow-derived mesenchymal stem cells from different bone sources: a panorama. Stem Cell Investig. 2020 Aug 10;7:15. doi: 10.21037/sci-2020-013. eCollection 2020.
Anz A, Sherman B. Concentrated Bone Marrow Aspirate Is More Cellular and Proliferative When Harvested From the Posterior Superior Iliac Spine Than the Proximal Humerus. Arthroscopy. 2022 Apr;38(4):1110-1114. doi: 10.1016/j.arthro.2021.10.011. Epub 2021 Oct 26.
Oliver K, Awan T, Bayes M. Single- Versus Multiple-Site Harvesting Techniques for Bone Marrow Concentrate: Evaluation of Aspirate Quality and Pain. Orthop J Sports Med. 2017 Aug 29;5(8):2325967117724398. doi: 10.1177/2325967117724398. eCollection 2017 Aug.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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RC Comp (BioCuff)
Identifier Type: -
Identifier Source: org_study_id
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