Cellular Content of Bone Marrow Aspiration, Comparison

NCT05573347 | Unknown

• 1 other identifier: RC Comp (BioCuff)
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational clinical trial is to determine whether the posterior superior iliac spine of the hip or the humerus of the arm will produce larger amounts of bone marrow when harvested during surgery. Also, the secondary goal of this study is to determine the effects of the patient's position on the quantity of cells harvested from the hip, namely lying on back (prone) vs. lying on side (lateral decubitus). The main questions it aims to answer are:

• 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.

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Outcome Measures

Primary Outcomes (1)

• Hemocytometer (Sysmex)

  Machine that separates blood cells into categories, including red blood cell (RBC), white blood cell (WBC), monocyte, platelet, and hematopoietic progenitor cell (HPC) groups to assess concentration

  Upon day of surgical procedure (once per participant)

Study Arms (2)

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.

Procedure: Rotator Cuff Repair; Procedure: Bone Marrow Harvest

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.

Procedure: Rotator Cuff Repair; Procedure: Bone Marrow Harvest

Interventions

Rotator Cuff Repair PROCEDURE

Surgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor)

Bone marrow harvest from patient lying prone; Bone marrow harvest from side-lying patient

Bone Marrow Harvest PROCEDURE

Procedure in which bone marrow cells are extracted, or harvested, from a given location in the body

Also known as: Bone Marrow Aspiration

Bone marrow harvest from patient lying prone; Bone marrow harvest from side-lying patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The focus demographic of this study is people within the ages of 18 and 80 that have been diagnoses with a rotator cuff tear and require reconstructive surgery.

You may qualify if:

• years of age
• Diagnosis of a rotator cuff tear requiring arthroscopic rotator cuff repair

You may not qualify if:

• Patients who require superior capsular reconstruction or revision rotator cuff repair
• 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

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• Florida: collaborator

Study Sites (1)

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32561, United States

RECRUITING

Related Publications (18)

• 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.

  PMID: 28144608 BACKGROUND

• 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.

  PMID: 26664409 BACKGROUND

• 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.

  PMID: 16778152 BACKGROUND

• 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.

  PMID: 24046512 BACKGROUND

• 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.

  PMID: 24913770 BACKGROUND

• 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.

  PMID: 19753178 BACKGROUND

• 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.

  PMID: 15995108 BACKGROUND

• 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.

  PMID: 23380230 BACKGROUND

• 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.

  PMID: 26354202 BACKGROUND

• 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.

  PMID: 17070744 BACKGROUND

• 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.

  PMID: 21773831 BACKGROUND

• 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.

  PMID: 23864180 BACKGROUND

• 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.

  PMID: 23783207 BACKGROUND

• 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.

  PMID: 23290182 BACKGROUND

• 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.

  PMID: 24066346 BACKGROUND

• 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.

  PMID: 32964008 BACKGROUND

• 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.

  PMID: 34715280 BACKGROUND

• 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.

  PMID: 28890905 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow aspirate from harvest

MeSH Terms

Conditions

Rotator Cuff Injuries; Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Joshua Hackel, MD

  Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessi Truett

CONTACT

8509168570; jessica.truett@andrewsref.org

Joshua Cook

CONTACT

8509168590; joshua.cook@andrewsref.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 10, 2022
• Study Start: August 16, 2022
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)