Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
NCT ID: NCT03956719
Last Updated: 2020-09-16
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
NA
8 participants
INTERVENTIONAL
2019-03-02
2020-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous adipose-derived mesenchymal stem cells
Patients receiving intra-articular injection of autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells is extracted from human abdominal fat, which is crushed, filtered and immediately returned to the articular cavity through a specific device.
abdominal liposuction
50 ml abdominal fat was extracted by abdominal liposuction to prepare autologous adipose-derived mesenchymal stem cells
Interventions
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Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells is extracted from human abdominal fat, which is crushed, filtered and immediately returned to the articular cavity through a specific device.
abdominal liposuction
50 ml abdominal fat was extracted by abdominal liposuction to prepare autologous adipose-derived mesenchymal stem cells
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of early stage degenerative arthritis by Radiographic Criteria and physical examination;
* Obviously extra-articular malformation;
* Course of disease ≥ six months;
* No medication for knee osteoarthritis in the past three months
* Evaluated has not at the risk of cancer;
* Subjects who understand and sign the consent form for this study.
Exclusion Criteria
* Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis;
* Cancer patients;
* Women who are pregnant or breast feeding,or allergic constitution patient;
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis;
* Receive other open surgery related to knee operation within 6 months;
* Participation in another clinical trial;
15 Years
65 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Principal Investigators
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Peilai Liu, MD
Role: STUDY_CHAIR
Qilu Hospital of Shandong University
Locations
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Qilu hospital of Shandong University
Jinan, Shandong, China
Countries
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References
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Yu D, Xu J, Liu F, Wang X, Mao Y, Zhu Z. Subchondral bone changes and the impacts on joint pain and articular cartilage degeneration in osteoarthritis. Clin Exp Rheumatol. 2016 Sep-Oct;34(5):929-934. Epub 2016 Aug 31.
Wilusz RE, Sanchez-Adams J, Guilak F. The structure and function of the pericellular matrix of articular cartilage. Matrix Biol. 2014 Oct;39:25-32. doi: 10.1016/j.matbio.2014.08.009. Epub 2014 Aug 27.
Fodor PB, Paulseth SG. Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Aesthet Surg J. 2016 Feb;36(2):229-36. doi: 10.1093/asj/sjv135. Epub 2015 Aug 3.
Awad ME, Hussein KA, Helwa I, Abdelsamid MF, Aguilar-Perez A, Mohsen I, Hunter M, Hamrick MW, Isales CM, Elsalanty M, Hill WD, Fulzele S. Meta-Analysis and Evidence Base for the Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells in Knee Cartilage Repair: Methodological Guidelines and Quality Assessment. Stem Cells Int. 2019 Apr 7;2019:3826054. doi: 10.1155/2019/3826054. eCollection 2019.
Senn-Malashonak A, Wallek S, Schmidt K, Rosenhagen A, Vogt L, Bader P, Banzer W. Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial. Bone Marrow Transplant. 2019 Nov;54(11):1827-1835. doi: 10.1038/s41409-019-0535-z. Epub 2019 May 14.
Browne JA, Nho SJ, Goodman SB, Callaghan JJ, Della Valle CJ. Stem Cells and Platelet-Rich Plasma Injections for Advanced Hip and Knee Arthritis: Enthusiasm Outpaces Science. J Arthroplasty. 2019 Jun;34(6):1049-1050. doi: 10.1016/j.arth.2019.03.074. Epub 2019 Apr 3. No abstract available.
Strotman PK, Novicoff WM, Nelson SJ, Browne JA. Increasing Public Interest in Stem Cell Injections for Osteoarthritis of the Hip and Knee: A Google Trends Analysis. J Arthroplasty. 2019 Jun;34(6):1053-1057. doi: 10.1016/j.arth.2019.03.002. Epub 2019 Mar 8.
Chareancholvanich K, Pornrattanamaneewong C, Narkbunnam R. Increased cartilage volume after injection of hyaluronic acid in osteoarthritis knee patients who underwent high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2014 Jun;22(6):1415-23. doi: 10.1007/s00167-013-2735-1. Epub 2013 Oct 27.
Other Identifiers
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2019042
Identifier Type: -
Identifier Source: org_study_id
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