In 2009 Hendrich C. et al., performed bone marrow Stem Cell (BMAC) transplants to 101 patients with AVN. The mean post-examination period for all patients was 14 months. Clinical-radiological progress of a total of 101 patients with various bone healing disturbances was documented. The study included 37 necrosis of the head of the femur, 32 avascular necroses/bone marrow edema of other localization, 12 non-unions, 20 other defects. The patients were re-examined clinically and radiologically and interviewed. Further surgery was necessary in 2 patients within the follow-up period. These were due to a progression of a collapsed head of the femur with initial necrosis. The latter healed after repeated osteosynthesis plus BMAC application without any consequences. Other than these 2 patients, no further complications were observed. In particular, no infections, no excessive new bone formation, no induction of tumor formation, as well as no morbidity due to the bone marrow aspiration. There were no specific complications within the follow-up period. In the authors’ opinion, the on-site preparation of the bone marrow cells within the operating theater had a safety advantage in the use of autologous cell therapy for bone regeneration.
84 patients were satisfied or very satisfied with the result of the operation, 7 patients reported moderate satisfaction and 1 patient, for whom the indication of a total hip replacement was made during the further course of recovery, evaluated the procedure as non-satisfactory. Independent of the total level of satisfaction, pain reduction was achieved in all patients.
Results indicated, the fracture healed uneventfully within three months. In all other patients, the clinical situation improved without further surgery.
Patients with avascular necrosis of the femoral head treated with this method have shown, no need for total joint replacement after an average of seven years in 94 of 116 patients.
REF: Hendrich, C., Engelmaier, F., Waertel, G., Krebs, R. and Jäger, M. (2009). Safety of autologous bone marrow aspiration concentrate transplantation: initial experiences in 101 patients. Orthopedic Reviews, 1(1), p.32.
Osteonecrosis of the femoral head is a debilitating skeletal disorder of unknown etiology that usually occurs in young males, can lead to collapse of the hip joint and may necessitate a total hip replacement.
Autologous adipose SVF has the capability to regenerate bone in the lesion of osteonecrosis of the femoral head. Case studies show, 3 months post treatment, VAS for pain, FRI, and ROM of the hips were improved, and there is MRI evidence of bone regeneration.
Subsequently another case series observation at 7 months and at 16 months respectively, showed symptom improvements and the MRIs showed positive bone regeneration. Patients clearly showed maintenance of the regenerated bone for a relatively long time period.
Following this, another patient was treated, three months after the injection, patient’s symptom completely resolved and the MRI findings of necrosis resolved completely as well. A subsequent MRI taken a few months later showed maintenance of the regenerated bone.
In a case report by Saxer et al. in 2016, autologous adipose SVF was used to treat proximal humeral fractures in eight patients.12 months after the procedure, biopsies of the repair tissue were performed. The biopsies demonstrated formation of bone ossicles that were structurally disconnected and the structure was distinct from osteoconducted bone. This suggests bone growth due to the implanted SVF cells. This study demonstrated spontaneous bone tissue and vessel formation within the fracture.
There have been case series published where patients with CMP have been treated with autologous adipose SVF. After 3 months of treatment, the patients’ symptoms improved in terms of VAS pain scale, FRI, and ROM. The study also showed positive regeneration of hyaline cartilage at the patellofemoral joints of the patients between pre- and post-treatment MRIs.
Pak et al. reported that autologous adipose SVF may be effective in treating meniscal tears. Case study revealed, 3 month post treatment results of the patient’s symptoms, measured with VAS scores for pain, FRI, and physical therapy ROM, had improved. Additionally, the regeneration of the meniscus cartilage was documented by pre- and post-treatment MRIs.
In 2016, de Girolamo et al. reported a result of randomized prospective clinical trial involving 56 patients with Achilles tendinopathy. Of the 56 patients, 28 patients were randomly assigned to a single PRP injection and the other 28 patients were assigned to a single SVF injection. All patients were assessed clinically using VAS, VISA-A, AOFAS and SF-36 questionnaires. Before the treatments, all patients also underwent ultrasound imaging studies and MRIs; these were then repeated at 4 and 6 month follow-ups. At the final follow-up, both patients group showed significant improvements in all scores compared to baseline. In the SVF injection patients, these improvements were faster and more pronounced. After 6 months, the MRI and ultrasound studies showed no significant difference. No side effects were observed in either group. The study concluded that both PRP and SVF are safe and effective treatments for tendinopathy, although adipose SVF may allow faster clinical results than PRP.
Lee et al. published an article in 2015 involving 12 patients with lateral epicondylosis treated with adipose-derived MSCs (ASCs). The study is a pilot study assessing the safety and efficacy of ASCs in treating human patients with lateral epicondylosis. The patients in this study were observed via VAS score, modified Mayo clinic performance index, and longitudinal and transverse ultrasound images. The tendon defect areas were evaluated at 6, 12, 26, and 52 weeks. Through 52 weeks of follow-up, VAS scores progressively decreased and elbow performance scores improved. Tendon defects, assessed by ultrasound images, also significantly decreased throughout the follow-up period. No significant adverse effects were observed.
SVF also has proven to regenerate cartilage, now SVF has shown improvements to bone density/regeneration via MRIs. Patients clearly show the repaired bones by SVF injection are maintained for a relatively long time period. This is a major therapeutic breakthrough.
AVASCULAR NECROSIS (AVN)
Patients with avascular necrosis have shown, no need for total joint replacement after an average of seven years.
TENDONIPATHY & TENDONITIS
CORTICOSTERIOD INJECTIONS WEAKEN THE TENDON AND INCREASE THE RISK OF RUPTURE.
These anti-inflammatory injections have been widely used for short-term pain relief, but they suppress the cellular activity of human tenocytes and collagen production. Short term pain relief is not worth long term damage.
Both PRP and SVF are safe and effective treatments for tendinopathy, although adipose SVF may allow faster clinical results than PRP.
CMP poses a major therapeutic challenge. However, as a few recent studies have shown the possibility of cartilage recovery using stem cells. The SVF treatment shows potential to treat CMP.
REF: Pak, J., Lee, J., Park, K., Park, M., Kang, L. and Lee, S. (2017). Current use of autologous adipose tissue-derived stromal vascular fraction cells for orthopedic applications. Journal of Biomedical Science, 24(1).
If you would like to read another literature review. The 2016 systematic review published in the Journal of Orthopaedic Surgery and Research can be found here.
Tags: Macquarie Stem Cells, Dr. Bright, Osteoarthritis Treatment, Dr. Ralph Bright, Stem Cell Therapy, Stem Cell Treatment, Stem Cells for Arthritis, Systematic Review, Literature Review