Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

Banc de Sang i Teixits23 enrolled

Overview

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression. XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue. The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the progression to collapse of the femoral head.

Prospective, open-label with blinded assessor, randomized, parallel, single-dose phase I-II clinical trial in which 24 patients affected with osteonecrosis of the femoral head ARCO grade I or II will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in osteonecrosis of the femoral head. Secondary objectives are to assess the efficacy of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and WOMAC Index). Patients will be randomized to one of the two treatment arms (core decompression and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue or the standard treatment of isolated core decompression). Thereafter, patients will be followed for 12 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Avascular Necrosis of Femur Head

Interventions

XCEL-MT-OSTEO-ALPHABIOLOGICAL

Core decompression plus XCEL-MT-OSTEO-ALPHA

Standard treatmentPROCEDURE

Isolated core decompression

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 to 50 years of age (male and female) * Osteonecrosis of the hip ARCO grade I or II * Abscence of systemic or local infection * Laboratory tests with no relevant abnormal findings that contraindicate the surgery. * Informed Consent Form signed * The patient is able to understand the nature of the study Exclusion Criteria: * Osteonecrosis of the hip secondary to femoral neck fracture * Patients with no closed cartilage * Surgical implants in the femoral head * Septic arthritis * Patients with severe renal insufficiency * Patients expecting or with liver transplantation * Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis. * Pregnant woman or intended to become pregnant, or breath feeding * Neoplasia within the previous 5 years, or without remission * Immunosuppressive states * The patient is legally dependent * Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days * Cardiac pacemaker, allergy to contrast or any other condition that contraindicates the MRI with contrast agents * Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria * The patient does not accept to be followed-up for a period thar could exceed the clinical trial length

Locations (1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Outcomes

Primary Outcomes

Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head

Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months

Time frame: 12 months

Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head

Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable.

Time frame: 12 months

Secondary Outcomes

Bone regeneration by measuring the necrotic angle using the modified Kerboul method

The necrotic angle will be measured using imaging procedures (magnetic resonance imaging MRI).

Time frame: 6 and 12 months

Dynamic changes of signal intensity

Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head

Time frame: 6 and 12 months

Clinical outcomes (pain) by Visual Analogue Scale (VAS)

Pain measurement by VAS

Time frame: 7 days and at 3, 6 and 12 months

Clinical outcomes (SF-36)

This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36

Time frame: 3, 6 and 12 months

Clinical outcome (WOMAC)

To assess the extent by which a person's functional level is restricted by the WOMAC index

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.