NCT01605383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
2.9 years until next milestone

Study Start

First participant enrolled

May 5, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

2.9 years

First QC Date

May 22, 2012

Last Update Submit

January 15, 2020

Conditions

Avascular Necrosis of Femur Head

Keywords

Avascular Necrosis of Femur HeadOsteonecrosis of the hipOsteonecrosis of the femoral headMesenchymal Stem CellsBone marrowTissue engineeringBone DiseasesMusculoskeletal Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

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

    6 and 12 months

  • Dynamic changes of signal intensity

    6 and 12 months

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

    7 days and at 3, 6 and 12 months

  • Clinical outcomes (SF-36)

    3, 6 and 12 months

  • Clinical outcome (WOMAC)

    3, 6 and 12 months

Study Arms (2)

XCEL-MT-OSTEO-ALPHA

EXPERIMENTAL

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

Biological: XCEL-MT-OSTEO-ALPHA

Standard Treatment

SHAM COMPARATOR

Isolated core decompression

Procedure: Standard treatment

Interventions

XCEL-MT-OSTEO-ALPHABIOLOGICAL

Core decompression plus XCEL-MT-OSTEO-ALPHA

XCEL-MT-OSTEO-ALPHA
Standard treatmentPROCEDURE

Isolated core decompression

Standard Treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25769789DERIVED

Related Links

MeSH Terms

Conditions

Femur Head NecrosisLegg-Calve-Perthes DiseaseBone DiseasesMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

OsteonecrosisNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Màrius Aguirre, MD, PhD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

May 5, 2015

Primary Completion

April 11, 2018

Study Completion

June 27, 2019

Last Updated

January 21, 2020

Record last verified: 2020-01

Locations

ES(1)