Musculoskeletal Cell Therapy
During the last 10 years, we have worked on the development of a somatic cell therapy to improve muscle regeneration. So far, we successfully demonstrated the effect and safety of an allogeneic cell therapy approach in 20 patients in a Phase I/II study. This allogenic cell therapy is now further tested in a multi-centre Phase III trial to determine its efficacy, safety and tolerability in 240 patients. It is worldwide the first trial of its kind to treat muscle injuries.
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Medical Need for a Musculoskeletal Cell Therapy
Hip fractures of the femoral neck are a major public health concern in the EU with an increasing incidence of 1 million patients per year. Approximately 50% of all neck of femur fractures are surgically treated with an internal fixation device, which is, however, prone to a high complication and revision rate (15% non-fusion). This is the reason why increasingly more neck of femur fractures are treated with hemi- or total arthroplasty. This allows the immediate total weight bearing mobilisation and should be life saving for these patients. Nevertheless, the mortality rates of these frail patients are the same whether they were treated with arthroplasty or with an internal fixation. The reasons for this are the muscle injury caused during arthroplasty, the patient's poor regeneration capacity and the immunological stress due to the trauma and the required surgery. Thus, the mortality rate of hip fracture patients within the first year following trauma is with 25-30% similar to the mortality rate of patients with malignant diseases. To date, no therapeutic option exists other than adjustments in the general set-up for the patients suffering from hip fracture, e.g. rehabilitation procedures.
Thus, there is a great need for the development of a new therapy for these patients in order to
Allogeneic PLX-PAD cells for the enhanced recovery following hip fracture surgery
We develop a new innovative allogeneic placental cell therapy with PLX-PAD cells for the enhanced recovery following hip fracture surgery.
PLX-PAD is an allogeneic cell-based dispersion for injection and classified as an Advanced Therapy Medicinal Product (ATMP). It comprises ex-vivo expanded placental adherent stromal cells that are derived from human placentae. The placentae are collected from healthy women undergoing elective Caesarean section. The placenta donors sign an informed consent form and are not compensated for this donation. No ethical issues are known to exist in the use of placenta derived stromal cells. PLX-PAD cells are manufactured, packaged and labelled by Pluristem Ltd. in GMP-compliant facilities located in Haifa, Israel.
Phase I/II Trial - Completed
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Regeneration of Injured Gluteal Musculature after Total Hip Arthroplasty
ClinicalTrials.gov Identifier: NCT01525667
EudraCT Number: 2011-003934-16
In this placebo-controlled study we assessed the safety and efficacy of intramuscular injections of allogeneic PLX-PAD cells to support regeneration of injured gluteal musculature after total hip arthroplasty in 20 subjects. On the treatment day, after suturing the gluteus medius muscle, PLX-PAD or placebo were applied directly to the site of laceration. Patients underwent follow-up examinations for efficacy assessment up to week 26 after surgery and for safety assessment such as adverse events, vital signs, ECG, routine lab and immunological testing for up to week 52 after surgery. Patients were also contacted by phone at week 104 in order to inquire about the occurrence of new cancer.
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, Designed to Determine the Efficacy, Safety and Tolerability of Intramuscular Injections of Allogeneic PLX-PAD Cells improved recovery following Arthroplasty for Hip Fracture.
EudraCT Number: 2015-005532-18
We currently perform a multi-center phase III clinical study with 240 patients to determine the efficacy, safety and tolerability of intramuscular injections of allogeneic PLX-PAD cells to improve recovery following arthroplasty for hip fracture. Internationally renowned European orthopaedic and trauma centres take part in this trial. The network consists of 9 partners from 8 Countries (Germany, Denmark, UK, Ireland, Italy, Switzerland, Israel and the United States). As a catalyst for improved patient engagement, an innovative patient platform implemented by Be the Partner will be used for the first time in an ATMP (Advanced therapy medical product) trial.