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

Primary Purpose

Hip Osteoarthritis, Hip Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Micro-fragmented adipose tissue injection
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring MF-AT, MF-AT injection, Mesenchymal stromal cells, Pilot study, Hip, Micro-fragmented Adipose Tissue

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 40 and 70 years;
  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:

  1. Patients unable to express consent;
  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).

Sites / Locations

  • Istituto Ortopedico Rizzoli
  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MF-AT injection

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Visual Analogue Scale (VAS)
VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable".
Harris Hip Scale (HHS)
This scale was developed for the evaluation of hip surgery outcomes and is intended to assess various hip disabilities and treatment methods in an adult population. The four sections that make up the questionnaire are: pain, function, absence of deformity, and range of motion. The HHS is a measure of dysfunction, so higher is the score, better is the outcome for the individual. The maximum possible score is 100.

Full Information

First Posted
July 15, 2022
Last Updated
May 9, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT05465096
Brief Title
Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.
Acronym
Lipo-Hip
Official Title
Interventional Pilot Study on the Treatment of Osteoarthritis of the Hip Joint With Intra-articular Ultrasound-guided Infiltration of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
For this pilot study, will be enrolled 30 patients with OA of the hip. All patients will be treated with a single infiltration of MF-AT obtained by the Lipogems® method. All activities of the present trial will be carried out at the Rizzoli Orthopaedic Institute (selection and enrollment, abdominal sampling, infiltrative treatment and follow-ups). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Hip Disease
Keywords
MF-AT, MF-AT injection, Mesenchymal stromal cells, Pilot study, Hip, Micro-fragmented Adipose Tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MF-AT injection
Arm Type
Experimental
Arm Description
Patients will be treated with an intra-articular-ultrasound-guided injection of Micro-fragmented adipose tissue containing mesenchymal stromal cells.
Intervention Type
Procedure
Intervention Name(s)
Micro-fragmented adipose tissue injection
Intervention Description
Intra-articular ultrasound-guided injection of MF-AT
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
Time Frame
6 months follow-up
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
Time Frame
baseline, 1 month, 3 months and 12 months follow-up
Title
Visual Analogue Scale (VAS)
Description
VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable".
Time Frame
baseline, 1 month, 3 months, 6 months and 12 months follow-up
Title
Harris Hip Scale (HHS)
Description
This scale was developed for the evaluation of hip surgery outcomes and is intended to assess various hip disabilities and treatment methods in an adult population. The four sections that make up the questionnaire are: pain, function, absence of deformity, and range of motion. The HHS is a measure of dysfunction, so higher is the score, better is the outcome for the individual. The maximum possible score is 100.
Time Frame
baseline, 1 month, 3 months, 6 and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Zaffagnini, MD
Phone
0516366567
Email
roberta.licciardi@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Licciardi, MSc
Phone
6366567
Ext
051
Email
roberta.licciardi@ior.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Zaffagnini, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Andriolo, MD
Phone
6366567
Ext
051
Email
luca.andriolo@ior.it
First Name & Middle Initial & Last Name & Degree
Roberta Licciardi, MSc
Phone
6366567
Ext
051
Email
roberta.licciardi@ior.it
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Zaffagnini, MD
Phone
6366567
Ext
051
Email
stefano.zaffagnini@ior.it
First Name & Middle Initial & Last Name & Degree
Roberta Licciardi, Msc
Phone
6366567
Ext
051
Email
roberta.licciardi@ior.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27072345
Citation
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.
Results Reference
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PubMed Identifier
27547712
Citation
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.
Results Reference
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PubMed Identifier
34206010
Citation
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.
Results Reference
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PubMed Identifier
33940131
Citation
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.
Results Reference
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PubMed Identifier
33344667
Citation
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.
Results Reference
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PubMed Identifier
26058927
Citation
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.
Results Reference
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PubMed Identifier
28630737
Citation
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.
Results Reference
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PubMed Identifier
29857166
Citation
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.
Results Reference
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PubMed Identifier
34706757
Citation
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.
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Citation
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Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.

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