Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees
NCT ID: NCT06562101
Last Updated: 2024-08-20
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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COMPLETED
NA
10 participants
INTERVENTIONAL
2020-12-04
2022-06-30
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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Stromal Vascular Fraction (SVF)
Ten patients with knee OA were administered intra-articular SVF injections.
Intra-articular Stromal Vascular Fraction Injection
Adipose tissue was harvested using the Q-graft system (Human Med®) from the abdominal subcutaneous fat of patients under local anesthesia. After concentration and resuspension in normal saline, 5 mL of the SVF suspension was injected into the knee joint cavity under sterile conditions.
Interventions
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Intra-articular Stromal Vascular Fraction Injection
Adipose tissue was harvested using the Q-graft system (Human Med®) from the abdominal subcutaneous fat of patients under local anesthesia. After concentration and resuspension in normal saline, 5 mL of the SVF suspension was injected into the knee joint cavity under sterile conditions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with degenerative knee OA confirmed via X-ray and classified according to the Kellgren Lawrence Grading Scale 2\~4.
* Persistent knee pain after nonsurgical treatment.
Exclusion Criteria
* Patients who have undergone total knee replacement surgery.
* Patients who have been administered platelet-rich plasma or hyaluronic acid injections within the past three months.
* Patients with symptoms related to degenerative arthritis in the ankle, which affected the assessment of pain.
* Patients with severe heart problems and coagulation disorders.
* Patients who have taken glucosamine within the previous month.
* MRI exclusion conditions, including patients with a heart rhythm regulator who have received vascular surgery with a hemostatic clip and artificial heart valves.
35 Years
ALL
No
Sponsors
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Shu-Hao Chang, MD
OTHER
Responsible Party
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Shu-Hao Chang, MD
Visiting staff
Principal Investigators
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Shu-Hao Chang, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopedics, Fu Jen Catholic University Hospital, Fu Jen Catholic University
Locations
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Fu Jen Catholic University Hospital
New Taipei City, , Taiwan
Countries
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References
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Abramoff B, Caldera FE. Osteoarthritis: Pathology, Diagnosis, and Treatment Options. Med Clin North Am. 2020 Mar;104(2):293-311. doi: 10.1016/j.mcna.2019.10.007. Epub 2019 Dec 18.
Lin FH, Chen HC, Lin C, Chiu YL, Lee HS, Chang H, Huang GS, Chang HL, Yeh SJ, Su W, Wang CC, Su SL. The increase in total knee replacement surgery in Taiwan: A 15-year retrospective study. Medicine (Baltimore). 2018 Aug;97(31):e11749. doi: 10.1097/MD.0000000000011749.
Taruc-Uy RL, Lynch SA. Diagnosis and treatment of osteoarthritis. Prim Care. 2013 Dec;40(4):821-36, vii. doi: 10.1016/j.pop.2013.08.003. Epub 2013 Sep 26.
Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Am J Sports Med. 2020 Mar;48(3):588-598. doi: 10.1177/0363546519899923.
Coughlin RP, Oldweiler A, Mickelson DT, Moorman CT 3rd. Adipose-Derived Stem Cell Transplant Technique for Degenerative Joint Disease. Arthrosc Tech. 2017 Oct 2;6(5):e1761-e1766. doi: 10.1016/j.eats.2017.06.048. eCollection 2017 Oct.
Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2.
Lindroos B, Suuronen R, Miettinen S. The potential of adipose stem cells in regenerative medicine. Stem Cell Rev Rep. 2011 Jun;7(2):269-91. doi: 10.1007/s12015-010-9193-7.
Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16.
Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006 Nov;33(11):2271-9. Epub 2006 Oct 1.
Xia B, Di Chen, Zhang J, Hu S, Jin H, Tong P. Osteoarthritis pathogenesis: a review of molecular mechanisms. Calcif Tissue Int. 2014 Dec;95(6):495-505. doi: 10.1007/s00223-014-9917-9. Epub 2014 Oct 14.
Krasnokutsky S, Samuels J, Abramson SB. Osteoarthritis in 2007. Bull NYU Hosp Jt Dis. 2007;65(3):222-8.
Anil U, Markus DH, Hurley ET, Manjunath AK, Alaia MJ, Campbell KA, Jazrawi LM, Strauss EJ. The efficacy of intra-articular injections in the treatment of knee osteoarthritis: A network meta-analysis of randomized controlled trials. Knee. 2021 Oct;32:173-182. doi: 10.1016/j.knee.2021.08.008. Epub 2021 Sep 6.
Aletto C, Giordano L, Quaranta M, Zara A, Notarfrancesco D, Maffulli N. Short-term results of intra-articular injections of stromal vascular fraction for early knee osteoarthritis. J Orthop Surg Res. 2022 Jun 11;17(1):310. doi: 10.1186/s13018-022-03196-0.
Friedrich KM, Shepard T, de Oliveira VS, Wang L, Babb JS, Schweitzer M, Regatte R. T2 measurements of cartilage in osteoarthritis patients with meniscal tears. AJR Am J Roentgenol. 2009 Nov;193(5):W411-5. doi: 10.2214/AJR.08.2256.
Zhang Y, Bi Q, Luo J, Tong Y, Yu T, Zhang Q. The Effect of Autologous Adipose-Derived Stromal Vascular Fractions on Cartilage Regeneration Was Quantitatively Evaluated Based on the 3D-FS-SPGR Sequence: A Clinical Trial Study. Biomed Res Int. 2022 Jan 25;2022:2777568. doi: 10.1155/2022/2777568. eCollection 2022.
Other Identifiers
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FJUH109069
Identifier Type: -
Identifier Source: org_study_id
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