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 "Patients treated with PLX-PAD had a greater
improved change of maximal voluntary muscle contraction force than
the placebo group," Israel-based Pluristem said in a statement on
Tuesday.
The trial was conducted at the Orthopedic Clinic of the Charite
University Medical School under the auspices of the
Paul-Ehrlich-Institute, Germany's health authority.
"This was a very important study not only for Pluristem but for the
cell therapy industry in general," Pluristem chief executive Zami
Aberman said. "Based on these results, we intend to move forward
with implementing our strategy towards using PLX cells in orthopedic
indications and muscle trauma."
The injured muscle studied was the gluteus medius muscle in the
buttock. Total hip replacement surgery via the standard transgluteal
approach necessitates injury of the gluteus medius muscle, and
post-operative healing is crucial for joint stability and function. "The study showed that PLX-PAD cells were safe and well tolerated,"
the statement said.
The primary efficacy endpoint of the study was the change in maximal
voluntary isometric contraction force of the gluteal muscle six
months after surgery.
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Efficacy was shown in two groups treated with the cells, with one
group receiving a 150 million cell dose displaying a 500 percent
improvement over the placebo group. Patients treated with a 300
million cell dose showed a 300 percent improvement over the placebo.
An analysis of the gluteal muscle indicated an increase in muscle
volume in those patients treated with PLX-PAD cells versus the
placebo group.
(Reporting by Tova Cohen)
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