A Medical Device Daily

Aastrom Biosciences (Ann Arbor, Michigan) reported that results from a European feasibility trial evaluating the use of its autologous Tissue Repair Cells (TRCs) suggest that TRCs may offer a new way to achieve local bone regeneration for bone grafting and other clinical indications for bone repair.

Tissue Repair Cells (TRCs) are Aastrom’s proprietary mixture of bone marrow-derived adult stem and progenitor cells produced using 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.

The feasibility trial was conducted with the Institut de Terapia Regenerativa Tisular (ITRT; Barcelona, Spain) to evaluate the use of TRCs for the treatment of severe long bone non-union fractures.

A report filed by the company with the U.S. Securities and Exchange Commission said that all of the patients treated with TRCs, a bone marrow-derived cell product, exhibited clinical and functional healing, with five of the six treatments showing bone regeneration at the fracture site as determined by radiographic imaging at six months.

Aastrom said the results were notable in that each patient had failed prior treatment with standard-of-care methodologies and had a “poor prognosis for healing.”

The trial was conducted at Hospital General de l’Hospitalet, Centro Medico Teknon and Hospital de Barcelona-SCIAS. Five patients were treated, one of whom received treatment for two separate fractures. All five patients had severe non-union fractures of a long bone (three tibia, two humeri, one clavicle), which had failed to heal in previous treatments.

The company said the patients all underwent open surgery to apply a metal plate internal fixation, replacing previous failed fixation, and TRCs were applied to aid in the local bone regeneration. The Aastrom TRCs were mixed with synthetic commercial matrix and an autologous fibrin, and applied directly at the fracture site.

The company said post-surgical evaluations of all patients are ongoing, using standard clinical and radiographic evaluations of the healing fracture site. Two of the patients have been evaluated for more than one year after surgery and a third has been monitored for more than eight months, with no complications or treatment-associated adverse effects observed.

Aastrom said the timing of the new bone growth, based on radiographs reading by a third-party expert radiologist, varied between patients. It said radiographically evident callus formation – bony tissue formed during the healing of a fractured bone – was first detected in five of six procedures at a mean of 11 weeks (minimum six weeks, maximum 24 weeks). The callus was judged to be stable by a mean of 17 weeks (minimum 10 weeks, maximum 24 weeks).

The company said all patients can bear weight on the treated fractured bone, have had their range of motion in the limb restored and are free from pain. Only one patient – the patient with two fractured legs – remains on occupational disability, because his job requires “a high level of physical effort,” according to Aastrom.

An “unexpected favorable clinical observation” cited by the researchers was that the inflammation and edema that are characteristic of typical bone grafting procedures in fracture-healing procedures were either reduced or were absent at the surgical site post-operatively in all patients.

“I am extremely encouraged by our first use of TRCs, and believe that they may represent a new tool in orthopedic medicine,” said Carlos Solano-Puerta, MD, the principal clinical investigator for the Barcelona trial. “Even though our patients had very severe fractures which had previously failed to heal, all exhibited good responses to the new treatment with TRCs, with the desired result of bone callus formation and bone remodeling.”

Aastrom said that with this clinical feasibility study completed, it is preparing to expand the long bone fracture trial in Barcelona to, it said, “implement several refinements in the procedure intended to further improve the use of TRCs in bone grafting.”

The company also is engaged in a related clinical trial of its TRCs at four centers in the U.S. The trial is using TRCs in conjunction with an allograft bone graft matrix provided by Aastrom’s partner, the Musculoskeletal Transplant Foundation (Edison, New Jersey). TRCs also are being used in a human clinical study in Spain for a different application: the generation of jaw bone preparatory to maxillary sinus lift procedures.

TRCs are the core component of the products Aastrom is developing for severe bone fractures, ischemic vascular disease, jaw reconstruction and spine fusion.

Coronado eyes European distribution

Coronado Industries (Fountain Hills, Arizona), maker of the Pneumatic Trabeculoplasty (PNT) device for the non-invasive treatment of glaucoma, said that as a precursor to signing a distribution agreement for the exclusive sale of the device in the UK, selected local ophthalmologists will be allowed to perform PNT treatments in their local hospitals and offices.

The PNT device is manufactured by a wholly owned subsidiary, Ophthalmic International.

Dr. Francesco Aspes, head of European operations for Coronado Industries, is in the UK this week for initial discussions with these selected doctors. He said, “As more and more PNT treatments are being performed successfully throughout Italy and Spain, the word gets out about what we’re doing and the huge benefits of PNT in the total management of a glaucoma patient.”

Contracts for the exclusive distribution of the device are being negotiated for France, German, Greece, Belgium and the UK. A distribution contract for Poland was signed last week with Meditherm.

Dr. John Sharkey, director of operations, said, “We have been contacted by interested companies from all over the world, [including] South America, India, China, Australia and Canada.”