European Knee Meniscus Injury Pilot Trial to Evaluate Cytori Cell Therapy Begins


Cytori Therapeutics is a cell therapy company that is in the process of developing cell therapies from a patient’s own fat tissue that can potentially treat a variety of medical conditions. To date, the preclinical studies and clinical trials suggest that their Cytori Cell Therapy can improve blood flow, modulate the immune system, and facilitating wound repair.

Recently, Cytori has announced that it has enrolled its first patients in an ambitious clinical trial that will test their stem cell product in patients undergoing surgery for traumatic injuries to the meniscus of the knee.  The meniscus is a wedge of cartilage on either side of the knee joint that acts a a shock absorber between the femur and the head of the tibia.

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Ramon Cugat, who is the Co-Director of the Orthopedic Institute, Hospital Quiron Barcelona, Spain, is the principal investigator for this trial. Dr. Cugat serves as an orthopedic surgeon at Hospital Quiron Barcelona. This trial will test the ability of Cytori Cell Therapy to heal the meniscus and is being conducted in parallel with a similar trial that is testing the Cytori Cell Therapy as a treatment for anterior cruciate ligament (ACL) repairs. The patients treated with Cytori Cell Therapy for ACL repairs are still being evaluated, but to date, no safety related concerns have emerged and the patients seem to have improved. These preliminary results were presented at the Barcelona Knee Symposium in November 2014.

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“Dr. Cugat is a leading expert in treating traumatic knee injuries in elite athletes,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “These trials are important to Cytori because, at minimal cost to us, they provide additional clinical evidence that our therapy can be safely used in treating a multitude of knee conditions.”

The meniscus trial is a two-center, phase I study that will assess the safety and efficacy of Cytori’s ECCM-50 adipose-derived regenerative cell therapy in meniscus repair. In this trial, up to 60 patients who have had meniscus surgery to repair the meniscus will receive injection of the cells directly into the meniscus. Each patient will be evaluated by several clinical read outs that assess the recovery of the patient after meniscus surgery. As in the case of the ACL repair study, the goal of this trial is to determine if Cytori Cell Therapy can be safely delivered to the meniscus and whether efficacy can be observed.

“Tears to the meniscus are problematic injuries for active individuals, particularly athletes. Based on the early results from a recent series of 20 patients treated for complete anterior cruciate ligament injuries, we are eager to evaluate whether augmentation surgery with Cytori Cell Therapy will lead to quicker and more complete healing,” said Dr. Cugat.

Injected patients will fill out a patient questionnaire that assesses knee pain, function and activity, This questionnaire is called the Knee Injury and Osteoarthritis Outcome Score (KOOS), but patients will also be physically examined to ascertain the extent of their knee function and the degree of their movement, with or without pain. Patients will be given a visual analogue score to assess knee pain, and knee function will be assessed by the Lysholm Knee Scoring Scale, Tegner Activity Scale, and the Lower Extremity Functional Scale. Each patient will also have their knees examined by Magnetic Resonance Imaging (MRI) in order to examine the structural integrity of their meniscus. These assessments will be taken before and 60, 90, 180 and 365 days after surgery and the MRIs will be done before and at 90, 180 and 365 days after surgery.

The preliminary results of the ACL study showed that the Cytori strategy was feasible and did not result in any significant safety issues above that seen with a standard small volume liposuction. All the injected patients recovered without any complications. The results of the ACL trial were compared to a historical control group of patients who had the same surgical procedure by the same surgical team but without other interventions. Overall, the patient’s recovery from pain and their ability to return to daily activities was accelerated as a result of the therapeutic enriched bone-patellar tendon-bone transplant. Both the patient questionnaires and serial MRI scans of the knees following cell therapy were consistent with accelerated healing of the graft. Presently, Dr. Cugat and his coworkers are obtaining one year follow-up information on the treated patients and they will report their data in a peer-reviewed journal in the future.

ACL and meniscus tears are among the most common sports-related knee injuries and unfortunately, these two injuries often are sustained simultaneously. According to the American Academy of Orthopedic Surgeons, ACL injuries have an annual incidence of more than 200,000 cases with nearly half undergoing surgical reconstruction. Further, an estimated 850,000 patients undergo surgical procedures to address meniscus injuries each year.

Stem Cell Therapy Following Meniscus Knee Surgery Reduces Pain and Regenerates Meniscus


According to a new study published in the January issue of the Journal of Bone and Joint Surgery (JBJS), a single stem cell injection after meniscus knee surgery can provide pain relief and aid in meniscus regrowth.

In the US alone, over one million knee arthroscopy procedures are performed each year. These surgeries are usually prescribed to treat tears to the wedge-shaped piece of cartilage on either side of the knee called the “meniscus.” The meniscus acts as an important shock absorber between the thighbone (femur) and the shinbone (tibia) at the knee-joint.

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This novel study, “Adult Human Mesenchymal Stem Cells (MSC) Delivered via Intra-Articular Injection to the Knee, Following Partial Medial Meniscectomy,” examined 55 patients who had undergone a surgical removal or all or part of a torn meniscus (known as a partial medial meniscectomy). Each patient was randomly assigned to one of three treatment groups: Groups A, B and C. The 18 patients in group A received a “low-dose” injection of 50 million stem cells within seven to 10 days after their meniscus surgery. Another 18 patients in group B received a higher dose of 150 million stem cells seven to ten days after their knee surgery. The controls group consisted of 19 patients who received injections of sodium hyaluronate only (no stem cells). All patients were evaluated to determine the safety of the procedure, the degree of meniscus regeneration (i.e. with MRI and X-ray images), the overall condition of the knee-joint, and the clinical outcomes through two years. Most of the patients enrolled in this study had some arthritis, but patients with severe (level three or four) arthritis, were excluded from the study.

Most of the patients who had received stem cell treatments reported a significant reduction in pain. 24 percent of the patients in one MSC group and 6 percent of the other showed at least a 15 percent increase in meniscal volume at one year. Unfortunately, there was no additional increase in meniscal volume at year two.

“The results demonstrated that high doses of mesenchymal stem cells can be safely delivered in a concentrated manner to a knee-joint without abnormal tissue formation,” said lead study author C. Thomas Vangsness, Jr., MD. “No one has ever done that before.” In addition, “the patients with arthritis got strong improvement in pain” and some experienced meniscal regrowth.

The key findings of this study are that there no abnormal (ectopic) tissue formation or “clinically important” safety issues identified. Also, 24 percent of the patients in the low-dose injection group (A) and six percent of the high-dose injection group (B) at one year showed “significantly increased meniscal volume,” as determined by an MRI, and this increase did not continue into the second year, but remained stable (should future studies try a second injection of MSCs?). Third, none of the patients in the control group (non-MSC group) showed significant meniscus regrowth. Finally, patients with osteoarthritis experienced a reduction in pain in the stem cell treatment groups, but there was no reduction in pain in the control (non-MSC group).

“The results of this study suggest that mesenchymal stem cells have the potential to improve the overall condition of the knee joint,” said Dr. Vangsness. “I am very excited and encouraged” by the results. With the success of a single injection, “it begs the question: What if we give a series of injections?”