Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions (EMPHA)

Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions in Hip Replacement Surgery

The aim of hip replacement surgery is to re-establish the physiological hip function and to obtain a stable fixation between the prosthetic components and the native bone. Commonly, the fixation is obtained by bone ingrowth between the prosthesis and the native bone. Thus, the quality of the patient's bone stock is essential to achieve this aim. However, several clinical conditions may impair the bone stock; therefore, in these cases bone grafts are necessary to improve the prosthetic fixation. The gold standard is represented by autologous bone grafts (from iliac crest or from acetabular bone chips) or allogeneic bone grafts from cadaveric femoral heads. Nevertheless, the osteogenic potential of multipotent cells derived from different anatomical regions has never been examined.

Thus, the aim of this study is to isolate multipotent cells from acetabular or femoral bone chips and from bone marrow aspirate of the same patient and to compare their osteogenic potential. The results of this study may reveal differences, which may have a clinical relevance for hip replacement surgery.

Study Overview

• Status: Unknown
• Conditions: Complications; Implant, Orthopedic
• Intervention / Treatment: Biological: Isolation of multipotent cells

• Study Type: Observational
• Enrollment (Anticipated): 13

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20161
    • Recruiting
    • IRCCS Istituto Ortopedico Galeazz
    • Contact: Laura Mangiavini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

13 patients undergoing hip replacement surgery will be selected. Samples from acetabulum, proximal femur (head of the femur) and from bone marrow will be collected for each patient.

Description

Inclusion Criteria:

• Patients undergoing hip replacement and affected by:

  1. hip osteoarthritis
  2. mild developmental dysplasia of the hip
• 18 ≤ Body Mass Index (BMI) ≤ 30 kg/m2

Exclusion Criteria:

• Rheumatoid arthritis
• Patients under pharmacological treatment for bone metabolic disorders
• Patient affected by metabolic disorders, which may affect bone metabolism
• Presence of bone metastases
• Presence of bone infections
• Patients undergoing hip revision surgeries
• Obesity (BMI ≥30kg/m2)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of differences in Colony Forming Units (CFU) percentage	Formation of CFUs will be evaluated in the three different samples (acetabular bone chips, femoral bone chis or bone marrow aspirated) and CFUs will be counted in each sample	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the osteogenic potential in the three different cell populations	Evaluation of Alizarin red stain. Analysis of bone markers (RUNX2, Collagen type I, Collagen type X, Alkaline Phosphatase)	1 year
Evaluation of the chondrogenic potential in the three different cell populations	Evaluation of Alcian blue stain in pellet culture. Analysis of chondrogenic markers (Collagen type II and SOX9)	1 year
Evaluation of the adipogenic potential in the three different cell populations	Evaluation of Oil red stain. Analysis of adipogenic markers (Peroxisome proliferator-activated receptor gamma (PPAR-γ), Lipoprotein lipase (LPL))	1 year

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Investigators: Principal Investigator: Laura Mangiavini, IRCCS Istituto Ortopedico Galeazzi

Publications and helpful links

General Publications

• Nguyen VT, Tessaro I, Marmotti A, Sirtori C, Peretti GM, Mangiavini L. Does the Harvesting Site Influence the Osteogenic Potential of Mesenchymal Stem Cells? Stem Cells Int. 2019 May 2;2019:9178436. doi: 10.1155/2019/9178436. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): June 14, 2020

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: EMPHA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No