Regenerative Medicine Published Research Abstracts
Regenerative Medicine of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy.
Degenerative disc disease (DDD) is a common cause of lower back pain with radicular symptoms and has a significant socioeconomic impact given the associated disability. Limited effective conservative therapeutic options result in many turning to surgical alternatives for management, which vary in the rate of success and also carry an increased risk of morbidity and mortality associated with the procedures. Several animal based studies and a few human pilot studies have demonstrated safety and suggest efficacy in the treatment of DDD with mesenchymal stem cells (MSCs). The use of bone marrow-derived MSCs for the treatment of DDD is promising and in the present study we report on the safety and efficacy findings from a registry based proof of concept study using a percutaneous intradiscal injection of cultured MSCs for the management of DDD with associated radicular symptoms.
Thirty-three patients with lower back pain and disc degeneration with a posterior disc bulge diagnosed on magnetic resonance imaging (MRI) met the inclusion criteria and were treated with culture-expanded, autologous, bone marrow-derived MSCs. Prospective registry data was obtained at multiple time intervals up to 6 years post-treatment. Collected outcomes included numeric pain score (NPS), a modified single assessment numeric evaluation (SANE) rating, functional rating index (FRI), measurement of the intervertebral disc posterior dimension, and adverse events.
Three patients reported pain related to procedure that resolved. There were no serious adverse events (i.e. death, infection, or tumor) associated with the procedure. NPS change scores relative to baseline were significant at 3, 36, 48, 60, and 72 months post-treatment. The average modified SANE ratings showed a mean improvement of 60% at 3 years post-treatment. FRI post-treatment change score averages exceeded the minimal clinically important difference at all time points except 12 months. Twenty of the patients treated underwent post-treatment MRI and 85% had a reduction in disc bulge size, with an average reduction size of 23% post-treatment.
Patients treated with autologous cultured MSCs for lower back pain with radicular symptoms in the setting of DDD reported minor adverse events and significant improvements in pain, function, and overall subjective improvement through 6 years of follow-up.
Abstract: The use of stem cells in orthopedics has been researched for many years, with robust animal data that show efficacy in cartilage healing, tendon repair, and intervertebral disk treatment. Early clinical data are also just starting to be published, and these results are encouraging. Safety data in large case series, some that lasted for many years, have also been published. The field of tissue engineering with stem cells in musculoskeletal impairments has the potential to reduce morbidity and improve clinical outcomes. The regulatory environment for this area of medicine is still developing.
Copyright © 2014 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved. PMID: 24439149
Percutaneous injection of autologous, culture-expanded mesenchymal stem cells into carpometacarpal hand joints: a case series with an untreated comparison group.
Centeno CJ, D Freeman M.
BACKGROUND: Mesenchymal stem cells (MSCs) show promising clinical potential as multipotent therapeutic agents in regenerative medicine, including a number of orthopedic applications. Objective: To study the possible value of MSC’s injected intra-articular in patients with carpometecarpal (CMC) joint and hand osteoarthritis (OA).
METHODS: This is a prospective, case series with an untreated control that was obtained through a convenience sample. Patients underwent a bone marrow aspiration with isolation and culture expansion of MSC’s using a serum free, autologous platelet lysate. Autologous MSC’s were injected intra-articular utilizing imaging guidance. Percentage improvement, functional and visual analog scale data was collected via survey at pre-procedure, 3 months, 6 months, and annually.
RESULTS: Six OA patients and four controls were recruited. The mean reported pain relief was significantly higher +60% in the thumb OA group (n=6, p=.032) than in the control -18.75% (n=4). The average time reporting was 11.83 +/- 5.70 months and 9.55 +/- 6.49 months for both groups, respectively. On average, a greater than 30% reduction were observed in all VAS scale metrics (n=5), average reporting time was 13 +/-5.52 months. The majority of patients (66.7%, n=6) reported an increase in both strength and range of motion, average reporting time was 11.83 +/- 5.7 months. No complications were reported.
CONCLUSIONS:Percutaneous implantation of cultured MSCs into the carpometecarpal joint was associated with patient reported improvement in pain and function that was not seen in an untreated control. In addition, all patients within this small case series reported no complications.
Regeneration of meniscus cartilage in a knee treated with percutaneously implanted autologous mesenchymal stem cells.
Centeno CJ, Busse D, Kisiday J, Keohan C, Freeman M, Karli D.
Regenerative Sciences Inc, Centeno-Schultz Clinic, Westminster, CO 80020, USA.
Mesenchymal stem cells are pluripotent cells found in multiple human tissues including bone marrow, synovial tissues, and adipose tissues. They have been shown to differentiate into bone, cartilage, muscle, and adipose tissue and represent a possible promising new therapy in regenerative medicine. Because of their multi-potent capabilities, mesenchymal stem cell (MSC) lineages have been used successfully in animal models to regenerate articular cartilage and in human models to regenerate bone. The regeneration of articular cartilage via percutaneous introduction of mesenchymal stem cells (MSC’s) is a topic of significant scientific and therapeutic interest. Current treatment for cartilage damage in osteoarthritis focuses on surgical interventions such as arthroscopic debridement, microfracture, and cartilage grafting/transplant. These procedures have proven to be less effective than hoped, are invasive, and often entail a prolonged recovery time. We hypothesize that autologous mesenchymal stem cells can be harvested from the iliac crest, expanded using the patient’s own growth factors from platelet lysate, then successfully implanted to increase cartilage volume in an adult human knee. We present a review highlighting the developments in cellular and regenerative medicine in the arena mesenchymal stem cell therapy, as well as a case of successful harvest, expansion, and transplant of autologous mesenchymal stem cells into an adult human knee that resulted in an increase in meniscal cartilage volume.
IV Nutritional Support Research
Platlet-Rich Plasma Research
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