Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.

NCT05465096 | Completed

• 1 other identifier: Lipo-Hip
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the safety and efficacy up to 12 months of MF-AT in the echo-guided infiltrative treatment of hip OA through clinical, subjective and objective evaluations.

Conditions

Hip Osteoarthritis; Hip Disease

Keywords

MF-AT; MF-AT injection; Mesenchymal stromal cells; Pilot study; Hip; Micro-fragmented Adipose Tissue

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome

  6 months follow-up

Secondary Outcomes (3)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline, 1 month, 3 months and 12 months follow-up

• Visual Analogue Scale (VAS)

  baseline, 1 month, 3 months, 6 months and 12 months follow-up

• Harris Hip Scale (HHS)

  baseline, 1 month, 3 months, 6 and 12 months follow-up

Study Arms (1)

MF-AT injection

EXPERIMENTAL

Patients will be treated with an intra-articular-ultrasound-guided injection of Micro-fragmented adipose tissue containing mesenchymal stromal cells.

Procedure: Micro-fragmented adipose tissue injection

Interventions

Micro-fragmented adipose tissue injection PROCEDURE

Intra-articular ultrasound-guided injection of MF-AT

MF-AT injection

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 70 years;
• 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);
• 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.
• Unilateral involvement;
• Ability and consent of patients to actively participate in clinical follow-up;
• Signature of informed consent.

You may not qualify if:

• Patients unable to express consent;
• Patients undergoing infiltration of other substance in the previous 6 months;
• Patients undergoing lower limb surgery to be treated in the previous 12 months;
• Patients with malignant neoplasms;
• Patients with rheumatic diseases;
• Patients with uncontrolled diabetes;
• Patients with uncontrolled thyroid metabolic disorders;
• Patients abusing alcoholic beverages, drugs or medications;
• Body Mass Index \> 35;
• Pregnant and/or fertile women.
• Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale.
• 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.
• Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (10)

• 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.

  PMID: 27072345 BACKGROUND

• 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.

  PMID: 27547712 BACKGROUND

• 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.

  PMID: 34206010 BACKGROUND

• 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.

  PMID: 33940131 BACKGROUND

• 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.

  PMID: 33344667 BACKGROUND

• 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.

  PMID: 26058927 BACKGROUND

• 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.

  PMID: 28630737 BACKGROUND

• 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.

  PMID: 29857166 BACKGROUND

• 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.

  PMID: 34706757 BACKGROUND

• 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.

  PMID: 30041472 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stefano Zaffagnini, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional pilot study

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: October 24, 2022
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)