Rotator Cuff Tear or Rupture, Not Specified as TraumaticBioCuffNCT05573347
Cellular Content of Bone Marrow Aspiration, Comparison
An observational study of Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by Andrews Research & Education Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- What is being tested?
- Rotator Cuff Repair and Bone Marrow Harvest
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 16 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18-80 years of age
- Diagnosis of a rotator cuff tear requiring arthroscopic rotator cuff repair
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Andrews Research and Education Foundation
Gulf Breeze, Florida, 32561
Jessi Truett, 850-916-8570, jessica.truett@andrewsref.org
Joshua Cook, 8509168590, joshua.cook@andrewsref.org
About this study
Official title: Comparison of the Cellular Content of Bone Marrow Aspiration From the Posterior Superior Iliac Spine and Deep Humeral Harvest in Patients Undergoing Rotator Cuff Repair
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.
Read the detailed description
This is a single site, comparative quantitative analysis study of the cellular characteristics of bone marrow aspirate from two extraction sites (PSIS and humerus) from patients undergoing standard-of-care arthroscopic rotator cuff repair surgery. 30 total patients will be recruited through the Andrews Institute physician practices. A recruitment flyer will be used to recruit participants. The flyer will be placed within physicians' offices and on social media platforms. Potential participants will be prescreened for inclusion and exclusion criteria through standard of care medical evaluations. Once a potential participant has agreed to be involved in the study, they will go through the described informed consent process. Patients meeting the inclusion criteria will have the study explained to them by one of the members of the research team, and they will be given an opportunity to participate if they are interested.
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.
- Being tested
- Rotator Cuff Repair, Bone Marrow Harvest
- Medical subject headings
- Rotator Cuff Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator Cuff RepairProcedure or surgery
Surgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor)
Bone Marrow HarvestProcedure or surgery
Also called Bone Marrow Aspiration
Procedure in which bone marrow cells are extracted, or harvested, from a given location in the body
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Rotator Cuff Repair; Procedure: Bone Marrow Harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Upon day of surgical procedure (once per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start16 Aug 2022
- Primary completion16 Aug 2023 (estimated)
- Study completion16 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tear or Rupture, Not Specified as TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Florida
- Responsible party
- Sponsor
- Investigators
- Joshua Hackel, MD, Principal investigator, Orthopedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573347
- Sponsor's protocol ID
- RC Comp (BioCuff)
- Acronym
- BioCuff
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28144608Marycz 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.
PubMed 26664409Rochefort 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.
PubMed 16778152Hauser 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.
PubMed 24046512Hernigou 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.
PubMed 24913770Hernigou 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.
PubMed 19753178Hernigou 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.
PubMed 15995108Saw 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.
PubMed 23380230Vangsness 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.
PubMed 26354202Kitoh 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.
PubMed 17070744Ellera 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.
PubMed 21773831Hyer 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.
PubMed 23864180Pierini 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.
PubMed 23783207Beitzel 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.
PubMed 23290182Marx 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.
PubMed 24066346
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cellular Content of Bone Marrow Aspiration From the Posterior Superior Iliac Spine and Deep Humeral Harvest in Patients Undergoing Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT05573347
- Acronym / sponsor ID
- BioCuff / RC Comp (BioCuff)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Collaborators
- Florida
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 16 Aug 2023 (estimated)
- Study completion
- 16 Aug 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single site, comparative quantitative analysis study of the cellular characteristics of bone marrow aspirate from two extraction sites (PSIS and humerus) from patients undergoing standard-of-care arthroscopic rotator cuff repair surgery. 30 total patients will be recruited through the Andrews Institute physician practices. A recruitment flyer will be used to recruit participants. The flyer will be placed within physicians' offices and on social media platforms. Potential participants will be prescreened for inclusion and exclusion criteria through standard of care medical evaluations. Once a potential participant has agreed to be involved in the study, they will go through the described informed consent process. Patients meeting the inclusion criteria will have the study explained to them by one of the members of the research team, and they will be given an opportunity to participate if they are interested.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow harvest from side-lying patient | – | Procedure: Rotator Cuff Repair, Procedure: Bone Marrow HarvestThis group will have bone marrow harvested from the PSIS extraction site while lying in the lateral decubitus position. |
| Bone marrow harvest from patient lying prone | – | Procedure: Rotator Cuff Repair, Procedure: Bone Marrow HarvestThis group will have bone marrow harvested from the PSIS extraction site while lying in the prone position. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18-80 years of age
- Diagnosis of a rotator cuff tear requiring arthroscopic rotator cuff repair
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotator Cuff RepairSurgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor) | Procedure or surgery | Bone marrow harvest from patient lying prone, Bone marrow harvest from side-lying patient |
| Bone Marrow HarvestAlso: Bone Marrow AspirationProcedure in which bone marrow cells are extracted, or harvested, from a given location in the body | Procedure or surgery | Bone marrow harvest from patient lying prone, Bone marrow harvest from side-lying patient |
Primary outcome
Hemocytometer (Sysmex)
Time frame: Upon day of surgical procedure (once per participant)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 28144608Akpancar 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.
- Background: PubMed 26664409Marycz 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.
- Background: PubMed 16778152Rochefort 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.
- Background: PubMed 24046512Hauser 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.
- Background: PubMed 24913770Hernigou 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.
- Background: PubMed 19753178Hernigou 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.
- Background: PubMed 15995108Hernigou 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.
- Background: PubMed 23380230Saw 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.
- Background: PubMed 26354202Vangsness 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.
- Background: PubMed 17070744Kitoh 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.
- Background: PubMed 21773831Ellera 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.
- Background: PubMed 23864180Hyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Hackel, MD principal investigator
Orthopedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by Andrews Research & Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessi Truett (8509168570, jessica.truett@andrewsref.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemocytometer (Sysmex) (time frame: Upon day of surgical procedure (once per participant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573347, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.