Last updated on March 2019

A Comparative Study of 2 Doses of BM Autologous H-MSC+Biomaterial vs Iliac Crest AutoGraft for Bone Healing in Non-Union

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nonunion of fracture
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age 18 to 65, both sexes
  2. Traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union.
  3. Able to understand, accept and sign informed consent
  4. Medical health coverage
  5. Able to understand and accept the study constraints

Exclusion Criteria:

  1. Hypertrophic non-unions
  2. Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc)
  3. Unrecovered vascular or neural injury
  4. Other fractures causing interference with weight bearing
  5. Visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.)
  6. Active infection of any location and aetiology
  7. Surgical contraindication of any cause
  8. Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
  9. Malignant tumour (past history or concurrent disease)(except carcinoma in situ or basalioma in remission)
  10. History of bone harvesting on iliac crest contraindicating new iliac crest bone graft harvesting or bone marrow collection
  11. Insulin dependent diabetes
  12. Any evidence (confirmed by PCR) of active infection with HIV, Hepatitis B or Hepatitis C infection
  13. Any evidence of Syphilis
  14. Known allergies to products involved in the production process of MSC
  15. Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion
  16. Autoimmune inflammatory disease
  17. Current treatment by biphosphonates not stopped three months prior to study inclusion
  18. Impossibility to meet at the appointments for the follow up
  19. Participation in another therapeutic trial in the previous 3 months
  20. Second non-union in case of bilateral or multiple non-unions (only one non-union per patient will be included in the trial)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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