Musculoskeletal Advanced Therapies
Despite the high incidence of muscle injuries, degenerative joint or spine diseses and other musculoskeletal disorders like tendon or bone pathologies, the basic issue - biological regeneration - has not yet been solved in clinical practice. Since 2006 we have been working on translational therapies in the field of musculoskeletal regeneration with the aim to bring innovative regenerative approaches to the patient.
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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
Phase I/II Studie - Abgeschlossen
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 investigated the safety and efficacy of intramuscular injections of allogeneic PLX-PAD cells to support regeneration of injured gluteal muscles after total hip arthroplasty in 20 patients. PLX-PAD or placebo were applied directly to the site of rupture on the day of treatment after suturing the gluteus medius muscle. Patients underwent a postoperative efficacy assessment until week 26 after surgery and a safety assessment including side effects, vital signs, ECG, routine laboratory and immunology until week 52 after surgery. In week 104, patients were also contacted by telephone to find out about the incidence of new cancer.
The results of the study showed an increase in muscle strength and volume in patients with hip endoprostheses and a reduction in early postoperative stress. This allogeneic cell therapeutic approach was successful in both efficacy and safety. This patient study is the first of its kind in the world to treat muscle injuries.
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.
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.