Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions

NCT ID: NCT03369457

Last Updated: 2019-04-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-10

Study Completion Date

2020-06-14

Brief Summary

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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.

Detailed Description

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Conditions

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Complications; Implant, Orthopedic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Isolation of multipotent cells

Isolation of multipotent cells from patient's cells. Analysis of CFU and differentiation potential

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Mangiavini

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

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IRCCS Istituto Ortopedico Galeazz

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Laura Mangiavini, Dr

Role: CONTACT

00390266214930

Facility Contacts

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Laura Mangiavini

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31191688 (View on PubMed)

Other Identifiers

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EMPHA

Identifier Type: -

Identifier Source: org_study_id

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