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Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell

Sponsored by Royan Institute

About this trial

Last updated 14 years ago

Study ID

Royan-Bone-004

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

12 to 75 Years
All Sexes

Trial Timing

Ended 15 years ago

What is this trial about?

Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields). Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce later surgeries required to augment the healing process and to accelerate the time to healing.

What are the participation requirements?

Inclusion Criteria

* Both genders are eligible

* Nonunion or delayed union diagnosed with X-Ray examination.

* More than 4 cm distance to joint

* Provided written informed consent

Exclusion Criteria

* Multiple major fracture or untreated major fracture

* Infected fracture

* HIV, hepatitis B or hepatitis C infection at the time of screening

* Pregnant or lactating women

* Diagnosis of cancer

* Active treatment with immunosuppressive drugs or anticoagulant agent

* Known allergic reaction to components of study treatment and/or study injection procedure