Title

Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head
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
  • Phase

    Phase 1/Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    23
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.
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.
Study Started
May 05
2015
Primary Completion
Apr 11
2018
Study Completion
Jun 27
2019
Last Update
Jan 21
2020

Biological XCEL-MT-OSTEO-ALPHA

Core decompression plus XCEL-MT-OSTEO-ALPHA

Procedure Standard treatment

Isolated core decompression

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

Standard Treatment Sham Comparator

Isolated core decompression

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
No Results Posted