Centeno-Schultz Clinic Abstract Accepted by Orthopedic Research Society
POSTED ON 9/30/2010 IN Industry News BY Christopher Centeno
Our abstract entitled Clinical Percutaneous Implantation of Autologous, Culture-Expanded MSCs into Peripheral Joints was accepted at the Orthopedic Research Society annual conference in Long beach California (Jan 2011). Abstract below:
Percutaneous Implantation of Autologous, Culture Expanded Mesenchymal Stem Cells into Peripheral Joints: One Year or Greater Follow-up with a Prospective Control Group
Christopher J. Centeno, Michael Freeman, John R. Schultz, Michelle Cheever, Stephen Faulkner, Ron Hanson, Sean Kohles Centeno-Schultz Clinic, Broomfield, CO.
INTRODUCTION: Mesenchymal stem cells (MSCs) show great clinical potential as therapeutic agents in regenerative medicine. These adult stem cells can be easily isolated from many areas in the body, and many animal studies have demonstrated their multipotency in terms of differentiating into muscle, bone, cartilage, tendon, and various cells of internal organs. We have previously published on a safety study (n=227) regarding orthopedic use of MSC's cultured in autologous platelet lysate to treat osteoarthritis (OA), showing a robust safety profile. In this study, patients underwent percutaneous implantation of MSC's cultured using the same technique to treat hip and knee OA. METHODS: 221 sequential knee and hip OA patients undergoing the procedure were prospectively followed using written questionnaires distributed via e-mail or by phone at set outcome time points. Bone marrow MSC's were obtained from bone marrow aspirates, isolated, and cultured using an autologous platelet lysate technique. The cultured cells were re-injected via imaging guidance into either the painful hip or knee. Pain relief was measured on a Likert scale of -90% to 100% improvement. A control group was recruited at the same time as the treatment group from patients choosing not to pursue the procedure. RESULTS: From the knee OA sample treated, 93 patients were male and 42 were female. The average age of treated knee patients (n=135) was 56.13 +/- 12.38 years and for hip patients it was 56.18 +/- 12.59 years (n=65). 41.4/63.2% of knee patients and 23.8/42.8% of hip patients reported >75%/>50% improvement respectively, see figure 1. Average reported relief was 53.12% in the knee OA group (n=133 reporting) and 30.35% in the hip OA group (n=42 reporting), there was a significant difference between the groups (p=0.003), see figure 2, with more outcome end-point drop-out in the hip group. Average reported improvement (n=29) in the control group was -2.75%. During the surveillance period, 4.1% of the knee patients and 21.5% of the hip patients reported undergoing a total arthroplasty procedure or had one planned, despite MSC therapy. Reported improvement increased over time at the 12 month and 24 month time points in the knee group. Of note, high Body mass Index (BMI) females (n=23) have a significantly lower proliferation rate (defined as total number of MSCs injected/days in culture) in culture (mean= 0.4358+/- 0.3702) when compared to high BMI males (n=86, mean=1.16+/- 0.916, p=8.813E-8), normal BMI females (n=31, mean= 0.8152+/- 0.6179, p=.007), and normal BMI males (n=32, mean=1.210+/-1.01, p=2.684E-4), see figure 3. Nanogram dexamethasone preconditioning in culture was associated with more improvement (n=82, mean= +53.59% SD=38.69, p=0.039) vs. the group without pre-conditioning (n=76, mean=+39.40%, SD=46.82). DISCUSSION: Percutaneous re-implantation of autologous MSC's was associated with patient reported relief. There was better improvement in knee vs. hip OA patients and reported relief was significantly better than an untreated prospective control group. Overweight females suffered from poor proliferation in culture and dexamethasone culture conditioning was associated with better clinical relief. These findings may have implications for other orthopedic applications involving MSC culture. Figure 1. The percentage of patients reporting >50% relief and >75% relief for knee and hip groups. Figure 2. The average percentage relief reported in all knee and hip OA patients. Figure 3. Proliferation rate comparisons in gender specific patients with varying BMI. REFERENCES: 1. Centeno, C.J., et al., Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther, 2010. 5(1): p. 81-93. NOTE: The hip patients in this sample included some patients with OA and AVN/ON. This data will also be reviewed with the AVN/ON patients taken out of the hip OA group to determine if this changes the outcome for the hip OA group.
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