Avascular Necrosis of Femur Head
Conditions
Keywords
Avascular Necrosis of Femur Head, Osteonecrosis of the hip, Osteonecrosis of the femoral head, Mesenchymal Stem Cells, Bone marrow, Tissue engineering, Bone Diseases, Musculoskeletal Diseases
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALXCEL-MT-OSTEO-ALPHA
Core decompression plus XCEL-MT-OSTEO-ALPHA
PROCEDUREStandard treatment
Isolated core decompression
Sponsors
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ministerio de Ciencia e Innovación, Spain
European Regional Development Fund
Banc de Sang i Teixits
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head | 12 months | Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months |
| Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes (pain) by Visual Analogue Scale (VAS) | 7 days and at 3, 6 and 12 months | Pain measurement by VAS |
| Bone regeneration by measuring the necrotic angle using the modified Kerboul method | 6 and 12 months | The necrotic angle will be measured using imaging procedures (magnetic resonance imaging MRI). |
| Clinical outcome (WOMAC) | 3, 6 and 12 months | To assess the extent by which a person's functional level is restricted by the WOMAC index |
| Clinical outcomes (SF-36) | 3, 6 and 12 months | This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36 |
| Dynamic changes of signal intensity | 6 and 12 months | Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head |
Countries
Spain
Outcome results
None listed