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Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

Primary Purpose

Avascular Necrosis of Femur Head

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
XCEL-MT-OSTEO-ALPHA
Standard treatment
Sponsored by
Banc de Sang i Teixits
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Avascular Necrosis of Femur Head focused on measuring 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

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

XCEL-MT-OSTEO-ALPHA

Standard Treatment

Arm Description

"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue (under Xcelia-GMP conditions)for osteonecrosis of the femoral head

Isolated core decompression

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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).
Dynamic changes of signal intensity
Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head
Clinical outcomes (pain) by Visual Analogue Scale (VAS)
Pain measurement by VAS
Clinical outcomes (SF-36)
This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36
Clinical outcome (WOMAC)
To assess the extent by which a person's functional level is restricted by the WOMAC index

Full Information

First Posted
May 22, 2012
Last Updated
January 15, 2020
Sponsor
Banc de Sang i Teixits
Collaborators
Ministerio de Sanidad, Servicios Sociales e Igualdad, Ministerio de Ciencia e Innovación, Spain, European Regional Development Fund
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1. Study Identification

Unique Protocol Identification Number
NCT01605383
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2015 (Actual)
Primary Completion Date
April 11, 2018 (Actual)
Study Completion Date
June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Banc de Sang i Teixits
Collaborators
Ministerio de Sanidad, Servicios Sociales e Igualdad, Ministerio de Ciencia e Innovación, Spain, European Regional Development Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XCEL-MT-OSTEO-ALPHA
Arm Type
Experimental
Arm Description
"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue (under Xcelia-GMP conditions)for osteonecrosis of the femoral head
Arm Title
Standard Treatment
Arm Type
Sham Comparator
Arm Description
Isolated core decompression
Intervention Type
Biological
Intervention Name(s)
XCEL-MT-OSTEO-ALPHA
Intervention Description
Core decompression plus XCEL-MT-OSTEO-ALPHA
Intervention Type
Procedure
Intervention Name(s)
Standard treatment
Intervention Description
Isolated core decompression
Primary Outcome Measure Information:
Title
Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
Description
Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months
Time Frame
12 months
Title
Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
Description
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 Outcome Measure Information:
Title
Bone regeneration by measuring the necrotic angle using the modified Kerboul method
Description
The necrotic angle will be measured using imaging procedures (magnetic resonance imaging MRI).
Time Frame
6 and 12 months
Title
Dynamic changes of signal intensity
Description
Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head
Time Frame
6 and 12 months
Title
Clinical outcomes (pain) by Visual Analogue Scale (VAS)
Description
Pain measurement by VAS
Time Frame
7 days and at 3, 6 and 12 months
Title
Clinical outcomes (SF-36)
Description
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
Title
Clinical outcome (WOMAC)
Description
To assess the extent by which a person's functional level is restricted by the WOMAC index
Time Frame
3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Màrius Aguirre, MD, PhD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25769789
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.
Results Reference
derived
Links:
URL
http://www.bancsang.net/
Description
Banc de Sang i Teixits. Xcelia-División de Terapias Avanzadas.
URL
http://www.vhebron.net/
Description
Hospital Universitari Vall d'Hebron, Barcelona

Learn more about this trial

Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

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