Trial | NCT02177565  Report issue

Official Title

Autologous Stem Cell Therapy for Fracture Non-union Healing

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    35
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.
Study Started
Jan 31
2000
Primary Completion
Oct 31
2011
Study Completion
Oct 31
2011
Last Update
Mar 11
2020

Biological carrier plus in vitro expanded autologous BMSCs

The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container

carrier plus BMSCs Experimental

carrier plus in vitro expanded autologous BMSCs

carrier alone (control). Placebo Comparator

Carrier alone

Criteria 

Inclusion Criteria:

An established non-union according to the US Food & Drug Administration criteria14.
Non-union following fracture of tibia or femur suitable for synthetic bone grafting.

Exclusion Criteria:

Skeletal immaturity.
Pregnant or breast-feeding.
Non-union following pathological fractures.
Positive to Hepatitis B, Hepatitis-C or HIV.
Infection during BMSC culture.
No Results Posted