Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

Avascular Necrosis of Femur Head Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605383
• Other study ID #: XCEL-MT-10-01
• Secondary ID: 2010-023998-18
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 5, 2015
• Est. completion date: June 27, 2019

Study information

• Verified date: January 2020
• Source: Banc de Sang i Teixits
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 27, 2019
• Est. primary completion date: April 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis of Femur Head
• Femur Head Necrosis
• Necrosis
• Osteonecrosis

Intervention

Biological:
• XCEL-MT-OSTEO-ALPHA
Core decompression plus XCEL-MT-OSTEO-ALPHA

Procedure:
• Standard treatment
Isolated core decompression

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Banc de Sang i Teixits	European Regional Development Fund, Ministerio de Ciencia e Innovación, Spain, Ministerio de Sanidad, Servicios Sociales e Igualdad

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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.	12 months
Secondary	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).	6 and 12 months
Secondary	Dynamic changes of signal intensity	Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head	6 and 12 months
Secondary	Clinical outcomes (pain) by Visual Analogue Scale (VAS)	Pain measurement by VAS	7 days and at 3, 6 and 12 months
Secondary	Clinical outcomes (SF-36)	This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36	3, 6 and 12 months
Secondary	Clinical outcome (WOMAC)	To assess the extent by which a person's functional level is restricted by the WOMAC index	3, 6 and 12 months

External Links

•   Banc de Sang i Teixits. Xcelia-División de Terapias Avanzadas.
•   Hospital Universitari Vall d'Hebron, Barcelona