Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.
NCT ID: NCT05465096
Last Updated: 2025-12-04
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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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2022-10-24
2025-12-31
Brief Summary
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Detailed Description
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Patients will undergo infiltrative treatment after collecting informed consent for study participation and biographical data. Thereafter, patients will be followed up with clinical evaluation at 1-3-6-12 months follow-up.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MF-AT injection
Patients will be treated with an intra-articular-ultrasound-guided injection of Micro-fragmented adipose tissue containing mesenchymal stromal cells.
Micro-fragmented adipose tissue injection
Intra-articular ultrasound-guided injection of MF-AT
Interventions
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Micro-fragmented adipose tissue injection
Intra-articular ultrasound-guided injection of MF-AT
Eligibility Criteria
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Inclusion Criteria
2. Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week);
3. Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute lesions) even if Grade 0.
4. Unilateral involvement;
5. Ability and consent of patients to actively participate in clinical follow-up;
6. Signature of informed consent.
Exclusion Criteria
2. Patients undergoing infiltration of other substance in the previous 6 months;
3. Patients undergoing lower limb surgery to be treated in the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with uncontrolled diabetes;
7. Patients with uncontrolled thyroid metabolic disorders;
8. Patients abusing alcoholic beverages, drugs or medications;
9. Body Mass Index \> 35;
10. Pregnant and/or fertile women.
11. Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale.
12. Patients with other hip pathologies: acetabular protrusion, concentric migration of the femoral head, presence of excessive deformity resulting from acetabular or femoral head dysplasia, collapse deformity, and deformed femoral head sequelae of Perthes disease or osteonecrosis of the femoral head.
13. Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).
40 Years
70 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Principal Investigators
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Stefano Zaffagnini, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Ortopedico Rizzoli
Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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References
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Filardo G, Perdisa F, Roffi A, Marcacci M, Kon E. Stem cells in articular cartilage regeneration. J Orthop Surg Res. 2016 Apr 12;11:42. doi: 10.1186/s13018-016-0378-x.
Tremolada C, Colombo V, Ventura C. Adipose Tissue and Mesenchymal Stem Cells: State of the Art and Lipogems(R) Technology Development. Curr Stem Cell Rep. 2016;2(3):304-312. doi: 10.1007/s40778-016-0053-5. Epub 2016 Jul 13.
Agarwal N, Mak C, Bojanic C, To K, Khan W. Meta-Analysis of Adipose Tissue Derived Cell-Based Therapy for the Treatment of Knee Osteoarthritis. Cells. 2021 Jun 1;10(6):1365. doi: 10.3390/cells10061365.
Meadows MC, Elisman K, Nho SJ, Mowry K, Safran MR. A Single Injection of Amniotic Suspension Allograft Is Safe and Effective for Treatment of Mild to Moderate Hip Osteoarthritis: A Prospective Study. Arthroscopy. 2022 Feb;38(2):325-331. doi: 10.1016/j.arthro.2021.04.034. Epub 2021 Apr 30.
Whitney KE, Briggs KK, Chamness C, Bolia IK, Huard J, Philippon MJ, Evans TA. Bone Marrow Concentrate Injection Treatment Improves Short-term Outcomes in Symptomatic Hip Osteoarthritis Patients: A Pilot Study. Orthop J Sports Med. 2020 Dec 9;8(12):2325967120966162. doi: 10.1177/2325967120966162. eCollection 2020 Dec.
Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.
Mardones R, Jofre CM, Tobar L, Minguell JJ. Mesenchymal stem cell therapy in the treatment of hip osteoarthritis. J Hip Preserv Surg. 2017 Mar 19;4(2):159-163. doi: 10.1093/jhps/hnx011. eCollection 2017 Jul.
Rodriguez-Fontan F, Piuzzi NS, Kraeutler MJ, Pascual-Garrido C. Early Clinical Outcomes of Intra-Articular Injections of Bone Marrow Aspirate Concentrate for the Treatment of Early Osteoarthritis of the Hip and Knee: A Cohort Study. PM R. 2018 Dec;10(12):1353-1359. doi: 10.1016/j.pmrj.2018.05.016. Epub 2018 May 29.
Mikkelsen RK, Blond L, Holmich LR, Molgaard C, Troelsen A, Holmich P, Barfod KW. Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial. Trials. 2021 Oct 27;22(1):748. doi: 10.1186/s13063-021-05628-4.
Pak J, Lee JH, Pak N, Pak Y, Park KS, Jeon JH, Jeong BC, Lee SH. Cartilage Regeneration in Humans with Adipose Tissue-Derived Stem Cells and Adipose Stromal Vascular Fraction Cells: Updated Status. Int J Mol Sci. 2018 Jul 23;19(7):2146. doi: 10.3390/ijms19072146.
Other Identifiers
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Lipo-Hip
Identifier Type: -
Identifier Source: org_study_id
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