Aastrom: Trial of TRCs with stem cells to treat severe fractures shows positive bone regeneration

By E. Janene Geiss

Philadelphia, March 22 - Aastrom Biosciences, Inc. said Wednesday that results of its phase 1/ 2 clinical trial evaluating the use of TRCs - a mixture of stem, stromal and progenitor cells derived from the patient's bone marrow - in the treatment of severe fractures that have failed prior treatment interventions show positive bone regeneration with no TRC-related adverse events.

The multi-center trial is ongoing and the results include data from the first seven patients of the trial, according to a company news release.

The results will be presented Wednesday by Matthew L. Jimenez at a symposium at the combined Orthopaedic Research Society and American Academy of Orthopaedic Surgeons meetings in Chicago. Jimenez, of the Illinois Bone & Joint Institute, is the principal investigator of the trial.

The results also include data from the first six months of observation after TRC, or Tissue Repair Cells, grafting that was combined with surgical correction of long-standing non-union fractures.

The results complement observations previously reported in Aastrom's European feasibility study, showing positive bone regeneration with no TRC-related adverse events, officials said.

The seven patients, treated at Lutheran General Hospital in Park Ridge, Ill., all had fractures of their tibia bone, which had failed to heal after one to three prior standard of care bone grafting and surgical treatments.

Previous treatment approaches included failures in internal and external fixation to align and immobilize the fractured bone, autologous bone grafting and bone morphogenetic protein supplementation, officials said.

The average period of time from the initial fractures to TRC treatment was 12 months. The TRC-treated patients, ages 30 to 73 years, underwent open reduction and internal fixation surgery in which TRCs were applied directly at the fracture site, together with an allograft bone matrix graft extender to promote local bone regeneration, officials said.

Bone regeneration, evidenced by callus formation or bone bridging, was observed in radiographs for all seven patients by six months. Early healing was seen in four of the patients by three months after treatment with TRCs, officials said.

Post-surgical evaluations of these patients using standard clinical and radiographic evaluations of the healing fracture site will continue over a 12-month period. The trial is accruing up to 36 patients, officials said.

"I am encouraged by the healing of these very difficult to treat fractures in these first few patients. The use of an autologous bone marrow-derived tissue product as an innovative cell therapy has the potential to provide a valuable alternative to some of the most difficult orthopedic challenges in trauma," Jimenez said in the release.

TRCs are Aastrom's proprietary mixture of bone marrow-derived adult stem, stromal and progenitor cells produced using patented single-pass perfusion technology in the AastromReplicell System.

The clinical procedure begins with the collection of a small sample of bone marrow from the patient's hip in an outpatient setting. TRCs are then produced in the automated AastromReplicell System over a 12-day period. It has been demonstrated in the laboratory that TRCs are able to develop into different types of tissue lineages in response to inductive signals, including hematopoietic (blood and immune systems), mesenchymal (connective tissues such as bone), adipose, and endothelial (vascular tubules). In clinical trials, TRCs have been shown to be safe in more than 200 patients.

Aastrom is an Ann Arbor, Mich., biotechnology company developing products for the repair or regeneration of multiple human tissues, based on its proprietary Tissue Repair Cell adult stem cell technology.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.