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These excerpts taken from the ASTM 10-K filed Aug 29, 2008. Other
Bone
In October 2007, positive 12 month results from our
U.S. Phase I/II clinical trial for the treatment of severe
long bone non-union fractures were reported at the Orthopedic
Trauma Association Annual Meeting in Boston, MA by the lead
clinical investigator. In the study, patients with non-union
tibia, humerus or femur fractures that had failed to heal after
one or more medical procedures (average 1.75) showed an overall
healing rate of 91% after one year. Overall, 34 patients
completed the six month post-treatment
follow-up
and 33 completed the 12 month
follow-up.
The 33 patients followed for 12 months showed an
overall healing rate of 91%, as determined by bone bridging
observed with radiographic imaging or computed tomography.
Results showed healing in 91% (21 of 23) of tibia
fractures, 100% (3 of 3) of humerus fractures, and 86% (6
of 7) of femur fractures. In addition to the 91% healing
rate observed after 12 months, results at six months showed
that early bone bridging successfully occurred in 85% (29 of
34) of patients and that signs of early healing (callus
formation) were present in 97% (33 of 34) of patients.
Three patients failed to complete the required
follow-up
visits. Though final data could not be collected from these
three patients, two showed healing by 18 weeks. No
cell-related adverse events were reported. The following centers
participated in the multi-center, prospective, open-label
clinical trial: Lutheran General Hospital,
Table of Contents
Park Ridge, IL; the University of Michigan Health System, Ann
Arbor, MI; William Beaumont Hospital, Royal Oak, MI; and
Lutheran Medical Center, Brooklyn, NY.
An initial five patient bone regeneration study was conducted at
three centers in Spain under Ethical Committee approval;
positive results were disclosed in May 2005. Following this
trial, a ten patient Phase II non-union fracture trial was
initiated. The Phase II study has completed enrollment and
BRC treatment of all ten patients, and we are continuing the
specified 24 months
follow-up of
these patients.
A Phase I/II spine fusion clinical trial is currently open at
William Beaumont Hospital, Royal Oak, MI. Patients are no longer
being enrolled but we are continuing regular patient
follow-up
for treated patients.
Other Bone In October 2007, positive 12 month results from our U.S. Phase I/II clinical trial for the treatment of severe long bone non-union fractures were reported at the Orthopedic Trauma Association Annual Meeting in Boston, MA by the lead clinical investigator. In the study, patients with non-union tibia, humerus or femur fractures that had failed to heal after one or more medical procedures (average 1.75) showed an overall healing rate of 91% after one year. Overall, 34 patients completed the six month post-treatment follow-up and 33 completed the 12 month follow-up. The 33 patients followed for 12 months showed an overall healing rate of 91%, as determined by bone bridging observed with radiographic imaging or computed tomography. Results showed healing in 91% (21 of 23) of tibia fractures, 100% (3 of 3) of humerus fractures, and 86% (6 of 7) of femur fractures. In addition to the 91% healing rate observed after 12 months, results at six months showed that early bone bridging successfully occurred in 85% (29 of 34) of patients and that signs of early healing (callus formation) were present in 97% (33 of 34) of patients. Three patients failed to complete the required follow-up visits. Though final data could not be collected from these three patients, two showed healing by 18 weeks. No cell-related adverse events were reported. The following centers participated in the multi-center, prospective, open-label clinical trial: Lutheran General Hospital,
Table of ContentsPark Ridge, IL; the University of Michigan Health System, Ann Arbor, MI; William Beaumont Hospital, Royal Oak, MI; and Lutheran Medical Center, Brooklyn, NY. An initial five patient bone regeneration study was conducted at three centers in Spain under Ethical Committee approval; positive results were disclosed in May 2005. Following this trial, a ten patient Phase II non-union fracture trial was initiated. The Phase II study has completed enrollment and BRC treatment of all ten patients, and we are continuing the specified 24 months follow-up of these patients. A Phase I/II spine fusion clinical trial is currently open at William Beaumont Hospital, Royal Oak, MI. Patients are no longer being enrolled but we are continuing regular patient follow-up for treated patients. | EXCERPTS ON THIS PAGE:
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