Phase I-II, multicentre clinical trial of the application of TRC* in the surgical treatment of non-hypertrophic pseudarthrosis in long bones

Nº EudraCT: 2005-001755-38

Objectives

Clinical trial to assess the efficacy, safety and effects TRC* infiltration on bone regeneration in hypertrophic and atrophic pseudarthrosis in long bones.

Methodology

Phase I-II, open-label, prospective and multicentre clinical trial. 10 patients with non-hypertrophic pseudarthrosis in long bones were included; 2 femurs, 3 tibiae, 3 clavicles and 1 ulna were intervened.

The application of TRC included in the biomaterial and plasma clot was performed in the focus of pseudarthosis. Patients were monitored over the following 24 months.

Safety was determined by the number of severe adverse effects (AEs) related to the study and the percentage of patients who had a related severe AE.

Efficacy was evaluated by radiographic criteria determined by the appearance of signs of “bone callus” formation 6 and 24 months after surgery.

Results

Safety
There were no adverse effects attributable to the cellular product. The postoperative course was uncomplicated except for those expected, due to the underlying pathology.

Efficacy
Evidence of efficacy was observed in 9 patients and healing was achieved in 7 patients. 2 patients required a complementary intervention and in only 1 case was it considered not curable
.

Conclusions

TRC show a favourable safety profile and offer a new therapeutic option for the treatment of pseudarthrosis.

Publications

Orozco L . Regeneración Ósea con Células progenitoras procedentes de medula ósea autóloga cultivadas ex vivo en bioreactor GM. En “Medicina regenerativa e ingeniería tisular. Del laboratorio a la clínica” * de Ascencio-GD: México, Alfil, 2009. ISBN: 978-607-7504-35-1

Orozco L. Altres cirurgies del genoll: Terapies Avançades. Revista de Cirurgia Ortopèdica i Traumatologia. Vol.VIII (2),2008. Ed. Societat Catalana de Cirurgia Ortopèdica i Traumatologia

Orozco L, Soler R. El ejemplo de ITRT y las “Células Madre Adultas”. Referent Ed Fundació Unió. 2008;Nº4.

Gómez-Barrena E, Orozco L, Munuera-Martínez L. Agentes locales en la consolidación ósea: perspectivas para el futuro. Revista de Ortopedia y Traumatología. 2006;50(Suppl 1):22-9.

STUDY DESCRIPTION

Multicentre study
Development phase: I-II
Status: concluido
PEI: 05-048
No. Eudra-CT: 2005-001755-38
Sponsor: Fundación Teknon
CEIC: Centro Médico Teknon
CRO: TFS, QUINTILES
Control: Spanish Medicine Agency (AEMPS)
Investigators: L Orozco, C Solano, R Soler Rich, J Girós
Scientific collaboration: S Palazzi, J Pous, S Vidal, Servicio Médicos de Mútua Universal
Cellular Production Unit: Centre de Teixits i Terapia Cel·lular (SCS)
Participating entities: Centro Médico Teknon; Hospital de Barcelona-SCIAS; Hospital Gral. de l’Hospitalet
Funding: Teknon Foundation, Aastrom Biosciencies Inc. (Michigan, USA)

*TRC: Tissue Repair Cells. Autologous Bone Marrow Progenitor Cells expanded with the Aastrom Replicell™ system