Clinical Evidence

This paper published in December 2019, reports on patients with advanced knee arthritis treated with Micro-fragmented Fat. The patients were monitored over a 24-month period. Their pain and function were recorded; and all had an MRI scan immediately before the treatment and 24 months after.

17 patients were enrolled and 10 fulfilled the criteria for follow-up. Three had a joint replacement and 4 were lost to follow-up. All of the 10 patients followed-up at 24 months showed a significant reduction in pain and an overall notable increase in the volume of cartilage measured on the contrast-enhanced MRI scan.

This study demonstrates a degree of regeneration of the cartilage which is associated with pain relief in a significant proportion of patients who had a single injection of micro-fragmented fat for knee arthritis.

Mr Ali Noorani “A further study in hip arthritis with femoral head osteonecrosis was published in 2018. The study included a total of 125 patient in bilateral hip osteonecrosis. The results are very interesting, this was a 30 year follow up of perspective randomised study of a large number of patients. These patients who had bilateral osteonecrosis i.e both hips are affected, the larger lesions were treated with BMAC and the smaller lesions were treated with just decompression. Overall, the results of bone marrow were clearly superior. Only 28% of the bone marrow group collapsed compared to 72% of the decompression group. In addition, only 24% of the patients had total hip replacement compared to 76% of just the decompression group.”

In this randomized, blinded study of 46 patients, 31 suffering with grade 2-3 osteoarthritis received ultrasound guided knee injections of an autologous protein solution (APS) derived from the nSTRIDE kit, which uses centrifugation to concentrate platelets, growth factors and anti-inflammatory cytokines from the blood. The other 15 received an injection of saline. Analysis after 12 months showed an excellent safety profile and a significant improvement in the WOMAC pain score (65% of patients) compared with the saline-treated controls (41%). The results support other published findings indicating a protective/pain relieving effect of APS that could benefit people with chronic moderate knee arthritis, with effects lasting for a year or more.

In this randomised clinical trial 57 patients with diabetes-related non-healing ulcers of the foot were treated with micro-fragmented adipose tissue (MFAT) injections, obtain. ed using the Lipogems system, at the injury site following forefoot or toe amputation. A further 57 patients were treated only with the gold standard conventional therapy following similar amputations. After 6 months, only 46% of the control group showed a fully healed wound whilst 80% of the Lipogems treated group recovered. No adverse events were recorded in the Lipogems treatment cohort. This study indicates that MFAT may have a valuable clinical application in supporting the safe natural and effective repair of complex or difficult to heal wounds.

Mr Ali Noorani “A study on rotator cuff tears was carried out and published in 2014. This is a case-controlled study with level 3 data. The patients were divided into two groups, one that received mesenchymal stem cells from bone marrow aspirate during arthroscopy and the other group that just had the arthroscopy. There was a total of 45 patients in each group and the rotator cuff tear sizes were between 1.4-2.5cm. In this study, when bone marrow aspirate was injected, a total of 150CCs of aspiration was carried out delivering 51,000 MSCs (4,300 CFU/ml) 8CC was injected into the greater tuberosity and 4CC at the repair site. The patients were followed up for 10 years and they had MRIs post operatively at 3 months, 6 months, 1 year, 2 years and at the most recent follow up (minimum 10 years). 100% of the patients in the bone marrow group had healed at 6 months versus 67% of the patients treated without bone marrow. At the 10 year follow up, in the bone marrow group 87% of the patients still had intact rotator cuffs whereas those who did not receive bone marrow treatment only 44% had intact rotator cuffs in the MRI scan. The study concluded that bone marrow aspirate MSCs was the most important variable in determining outcomes in these groups of patients.”

A more recent study by Ahmad et al 10 looked at the use of PRP injections versus extra corporeal shock-wave therapy for chronic lateral epicondylitis. This study had a minimum of a 2 years follow up was a retrospective comparison study and concluded that both PRP injections and extra corporeal shock-wave therapy are safe options for treatment for chronic lateral epicondylitis and there is low risk of complications and with good long-term follow up results. However, they did note that ultrasound guided PRP injections was quicker in achieving symptom resolution. The mean time to return to active normal life was also quicker with PRP when compared to shockwave therapy.