Clinical trial NCT01605383: Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head
Official title: A Pilot Clinical Trial of "ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue (XCEL-MT-OSTEO- ALPHA) in Osteonecrosis of the Femoral Head
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Avascular Necrosis of Femur Head
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
Lead sponsor: Banc de Sang i Teixits
Sponsor class: OTHER
Collaborators: name: Ministerio de Sanidad, Servicios Sociales e Igualdad
name: Ministerio de Ciencia e Innovación, Spain
name: European Regional Development Fund
First posted: 2012-05-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
timeFrame: 12 months
measure: Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
timeFrame: 12 months
Secondary outcomes:
measure: Bone regeneration by measuring the necrotic angle using the modified Kerboul method
timeFrame: 6 and 12 months
measure: Dynamic changes of signal intensity
timeFrame: 6 and 12 months
measure: Clinical outcomes (pain) by Visual Analogue Scale (VAS)
timeFrame: 7 days and at 3, 6 and 12 months
measure: Clinical outcomes (SF-36)
timeFrame: 3, 6 and 12 months
measure: Clinical outcome (WOMAC)
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Màrius Aguirre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.