PLX-PAD, stem cell therapy for the treatment of critical limb ischemia (CLI) and end-stage of peripheral artery disease (PAD) by Pluristem Therapeutics, has been found safe in human trials.
PLX-PAD is a placenta-derived cell therapy product.
PLX-PAD is safe, well tolerated and effective, Pluristem Therapeutics Inc said announcing interim results from its phase I clinical trials utilizing it for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
A total of twenty-one patients in the U.S. and Germany, have been dosed with PLX-PAD. This includes fifteen patients dosed in Germany, representing the complete patient enrollment in that country.
These Phase I studies were designed to evaluate the safety of PLX-PAD in patients with CLI. Both trials have currently met their primary safety endpoints.
Additionally, the administration of PLX-PAD cells did not induce an immune response in any of the patients dosed, demonstrating that injection of PLX-PAD cells is well tolerated.
“Comprehensive immunological testing of patients has demonstrated that PLX-PAD cells can be injected in three dose levels without demonstrating serious adverse effects,” stated Hans-Dieter Volk, Ph.D., professor of immunology and chair of the Institute of Medical Immunology Charite – Universitmedizin Berlin and Berlin-Brandenburg Center for Regenerative Therapies (BCRT).
This finding is a further indication that PLX-PAD is well-tolerated and a promising treatment for critical limb ischemia (CLI), he added.
Twelve of the twenty one patients dosed have completed their three-month follow-up.
Patient improvement was assessed by analyzing the hemodynamic measurements as defined in the efficacy parameters in the study protocol: the ankle-brachial index (ABI), toe-brachial index (TBI) and transcutaneous oxygen tension (TcPO2).
Ten of these twelve patients (83%) demonstrated an improvement in at least one of these parameters, with 95% Confidence Interval .
The interim results of this study have demonstrated that PLX-PAD cells can be administered without evoking the patient’s immune response and that the majority of the patients benefited from the PLX-PAD therapy, experts said.
In India, Stempeutics Research Pvt Ltd (SRPL), a part of the Manipal Education & Research Group, is also developing a mesenchymal stem cell therapy Stempeucel for treating Critical Leg Ischemia (CLI).
Stempeuticel is expected to undergo phase-III study on 120 patients at hospitals across the country.
Stempeutics has completed pre-clinical studies demonstrating the appropriate safety profile of human bone marrow-derived ex vivo cultured adult mesenchymal stem cells in allogenic settings.
Stempeutics is currently doing clinical research to establish the efficacy of the stem cell therapy in acute myocardial infarction (heart attack) and critical limb ischemia.
A phase 3 study using adult allogenic mesenchymal stem cells is planned to be conducted in India in 2011
Stempeutics is also planning to conduct another phase III study outside India. This second phase 3 is likely to be supportive for the registration of the product in ASEAN countries.
Stempeutics is planning to file new drug application (NDA) in India in the coming years.