Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
NCT ID: NCT02863926
Last Updated: 2024-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2017-01-06
2018-07-27
Brief Summary
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Detailed Description
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Patients will undergo amputation and injection sites will be harvested at that time. Immunohistochemical staining (IHC) will determine capillary density and local host immune responses. Angiogenic and inflammatory cytokines will be quantified using a multiplex array system and quantitative polymerase chain reaction (PCR).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Day 7
BKA performed at 7 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg
Injection of cBMA aspirate into the index leg
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Day 14
BKA performed at 14 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg
Injection of cBMA aspirate into the index leg
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Day 21
BKA performed at 21 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg
Injection of cBMA aspirate into the index leg
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Interventions
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Injection of cBMA aspirate into the index leg
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients requiring below knee amputation, as determined by an independent vascular specialist.
3. If ulceration or gangrene present, it is distal to malleoli (to allow adequate length of ATM for 4 injections 4 cm. apart)
4. BKA can safely be performed up to 30 days after screening, as determined by an independent vascular or orthopedic surgeon. This information will be documented in subjects' case report forms (CRFs).
5. Females of childbearing potential must be willing to use one form of birth control for the duration of the study. Female participants must undergo a blood or urine pregnancy test at screening.
Exclusion Criteria
2. Significant hepatic dysfunction (ALT or AST greater than 2 times normal).
3. CHF hospitalization within the last 1 month prior to enrollment.\*
4. Acute coronary syndrome (ACS) in the last 1 month prior to enrollment.\*
5. HIV positive, or active, untreated HCV.
6. History of cancer within the last 5 years, except basal cell skin carcinoma
7. Any bleeding diathesis defined as an INR ≥ 2.0 (off anticoagulation therapy) or history of platelet count less than 70,000 or hemophilia.
8. Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted).
9. Concurrent enrollment in another clinical investigative trial.
10. Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata).
11. Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial.
* As defined by the standard definitions of CHF and ACS by the American Heart Association.
40 Years
90 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Michael Murphy
OTHER
Responsible Party
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Michael Murphy
Principal Investigator, MD
Principal Investigators
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Michael P Murphy, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University School of Medicine
Indianapolis, Indiana, United States
Countries
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References
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Santilli JD, Santilli SM. Chronic critical limb ischemia: diagnosis, treatment and prognosis. Am Fam Physician. 1999 Apr 1;59(7):1899-908.
Albers M, Fratezi AC, De Luccia N. Assessment of quality of life of patients with severe ischemia as a result of infrainguinal arterial occlusive disease. J Vasc Surg. 1992 Jul;16(1):54-9.
Huang PP, Li SZ, Han MZ, Xiao ZJ, Yang RC, Qiu LG, Han ZC. Autologous transplantation of peripheral blood stem cells as an effective therapeutic approach for severe arteriosclerosis obliterans of lower extremities. Thromb Haemost. 2004 Mar;91(3):606-9. doi: 10.1160/TH03-06-0343.
Cruz CP, Eidt JF, Capps C, Kirtley L, Moursi MM. Major lower extremity amputations at a Veterans Affairs hospital. Am J Surg. 2003 Nov;186(5):449-54. doi: 10.1016/j.amjsurg.2003.07.027.
Dillingham TR, Pezzin LE, MacKenzie EJ. Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J. 2002 Aug;95(8):875-83. doi: 10.1097/00007611-200208000-00018.
Dillingham TR, Pezzin LE, Shore AD. Reamputation, mortality, and health care costs among persons with dysvascular lower-limb amputations. Arch Phys Med Rehabil. 2005 Mar;86(3):480-6. doi: 10.1016/j.apmr.2004.06.072.
Castronuovo JJ Jr, Deane LM, Deterling RA Jr, O'Donnell TF Jr, O'Toole DM, Callow AD. Below-knee amputation: is the effort to preserve the knee joint justified? Arch Surg. 1980 Oct;115(10):1184-7. doi: 10.1001/archsurg.1980.01380100032007.
Nehler MR, Coll JR, Hiatt WR, Regensteiner JG, Schnickel GT, Klenke WA, Strecker PK, Anderson MW, Jones DN, Whitehill TA, Moskowitz S, Krupski WC. Functional outcome in a contemporary series of major lower extremity amputations. J Vasc Surg. 2003 Jul;38(1):7-14. doi: 10.1016/s0741-5214(03)00092-2.
Lim TS, Finlayson A, Thorpe JM, Sieunarine K, Mwipatayi BP, Brady A, Abbas M, Angel D. Outcomes of a contemporary amputation series. ANZ J Surg. 2006 May;76(5):300-5. doi: 10.1111/j.1445-2197.2006.03715.x.
Prockop DJ. Repair of tissues by adult stem/progenitor cells (MSCs): controversies, myths, and changing paradigms. Mol Ther. 2009 Jun;17(6):939-46. doi: 10.1038/mt.2009.62. Epub 2009 Mar 31.
Markel TA, Wang Y, Herrmann JL, Crisostomo PR, Wang M, Novotny NM, Herring CM, Tan J, Lahm T, Meldrum DR. VEGF is critical for stem cell-mediated cardioprotection and a crucial paracrine factor for defining the age threshold in adult and neonatal stem cell function. Am J Physiol Heart Circ Physiol. 2008 Dec;295(6):H2308-14. doi: 10.1152/ajpheart.00565.2008. Epub 2008 Oct 10.
Kinnaird T, Stabile E, Burnett MS, Shou M, Lee CW, Barr S, Fuchs S, Epstein SE. Local delivery of marrow-derived stromal cells augments collateral perfusion through paracrine mechanisms. Circulation. 2004 Mar 30;109(12):1543-9. doi: 10.1161/01.CIR.0000124062.31102.57. Epub 2004 Mar 15.
Seok J, Warren HS, Cuenca AG, Mindrinos MN, Baker HV, Xu W, Richards DR, McDonald-Smith GP, Gao H, Hennessy L, Finnerty CC, Lopez CM, Honari S, Moore EE, Minei JP, Cuschieri J, Bankey PE, Johnson JL, Sperry J, Nathens AB, Billiar TR, West MA, Jeschke MG, Klein MB, Gamelli RL, Gibran NS, Brownstein BH, Miller-Graziano C, Calvano SE, Mason PH, Cobb JP, Rahme LG, Lowry SF, Maier RV, Moldawer LL, Herndon DN, Davis RW, Xiao W, Tompkins RG; Inflammation and Host Response to Injury, Large Scale Collaborative Research Program. Genomic responses in mouse models poorly mimic human inflammatory diseases. Proc Natl Acad Sci U S A. 2013 Feb 26;110(9):3507-12. doi: 10.1073/pnas.1222878110. Epub 2013 Feb 11.
Deutsch MA, Sturzu A, Wu SM. At a crossroad: cell therapy for cardiac repair. Circ Res. 2013 Mar 15;112(6):884-90. doi: 10.1161/CIRCRESAHA.112.275974. No abstract available.
Wang L, Cao L, Shansky J, Wang Z, Mooney D, Vandenburgh H. Minimally invasive approach to the repair of injured skeletal muscle with a shape-memory scaffold. Mol Ther. 2014 Aug;22(8):1441-1449. doi: 10.1038/mt.2014.78. Epub 2014 Apr 28.
Murphy MP, Lawson JH, Rapp BM, Dalsing MC, Klein J, Wilson MG, Hutchins GD, March KL. Autologous bone marrow mononuclear cell therapy is safe and promotes amputation-free survival in patients with critical limb ischemia. J Vasc Surg. 2011 Jun;53(6):1565-74.e1. doi: 10.1016/j.jvs.2011.01.074. Epub 2011 Apr 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1511774456
Identifier Type: -
Identifier Source: org_study_id