Multicentre, Phase IIa Clinical Trial Application of TRC to the treatment of atrophic pseudarthrosis of long bones (Tissue Repair Cells from Aastrom Biosciences - Michigan, USA)

Multicentre, Phase IIa Clinical Trial Application of TRC to the treatment of atr

Pseudarthrosis or non-union is the term applied to a fracture when it fails to unite within a time considered adequate for healing to have taken place. In some cases, failure of successive treatments to deal with the non-union leads to a situation known as recalcitrant pseudarthrosis.

ITRT participated in designing and conducting studies to assess the efficacy of grafts consisting of tissue repair cells (TRC), a cell product obtained after a process of selection and culture of the bone marrow progenitor cells of a patient at the Banc de Sang i Teixits (BST) [Blood & Tissue Bank] using the Aastrom Replicell System bioreactor.

In 2005, ITRT was the driving force behind a multicentre study sponsored by Fundación Teknon and  supervised by the Spanish Agency for Medicines and Medical Devices (AEMPS) in which TRC were used as the main component of bone grafts implanted into recalcitrant atrophic pseudarthroses. The trial was completed in 2008 and the Centro Médico Teknon, Hospital Gral. De l'Hospitalet and Hospital de Barcelona-SCIAS toop art in it.
 
The study included 10 patients: 9 showed clear signs of bone regeneration (7 were cured and  2 required additional surgery), and 1 was considered incurable. 
After 4 years of follow-up of the last patient to be included, no adverse effects or complications caused by the cell product had been reported.

As a result of the satisfactory outcomes and lack of complications, the Spanish Agency  for Medicines and Medical Devices continues to regularly authorise the research team to apply the technique with mesenchymal progenitor cells  as treatment on a "compassionate use" basis.