Publications

New Lipocell publication for early osteoarthritis

A new Lipocell article has been published. We are grateful to all authors guided by Prof. Nicola Maffulli and Dr. Donato Notarfrancesco for testing our medical device for the treatment of knee osteoarthritis.

The paper out in Journal of Orthopaedic Surgery and Research showed the short-term results of Lipocell treatment for early osteoarthritis in 123 patients. There was a statistically significant improvement of KOOS and VAS of all patients to 6 months (p < 0.05). The mean KOOS before injection was 51.4 ± 16.5, after 1 month it was 75.5 ± 15.8, and at 6 months it was 87.6 ± 7.7. The patients’ mean VAS before injection was 6.5, after 1 month it was 3.5, and after 6 months it was 2.4. No complications were observed.

The full article is available here.

New Lipocell publication for the treatment of osteoarthritis

There is a new article that demonstrates the safety and efficacy of Lipocell in the treatment of osteoarthritis. The research work, carried out by Dr. Marco Caforio and Prof. Carmelo Nobile, was published in the Journal of Clinical Medicine (I.F. 3.3) within the Special Issue “Recent Advances in Osteoarthritis Management and Regenerative Strategies”.

The study, approved by the ethics committee of the University of Calabria, recruited thirty patients who showed improvements in their symptoms of pain and loss of joint function after infiltration of purified autologous adipose tissue obtained with Lipocell, in association with arthroscopic lavage and debridement.

Lipocell now has three peer-reviewed papers demonstrating its efficacy in osteoarthritis treatment (see Castellarin et al., Bistolfi et al.).

Dr. Marco Caforio’s paper is available here.

New Lipocell clinical study in orthopedics

We are proud to share a new clinical study on Lipocell, published by Dr. Gianluca Castellarin, orthopaedic surgeon expert in regenerative medicine.

The study shows the long-term benefits of Lipocell infiltration in patients with osteoarthritis. In particular, it shows the results on 92 patients (59 males, 33 females) with average age 52 and osteoarthritis grade II or II on the Outerbridge scale.

About pain symptoms, the patients show a 50% reduction already at the first follow-up at one month and, at one year later, an average value of 1 VAS scale point, which corresponds to a near absence of pain. According to the functionality, measured with the Womac questionnaire, patients recover significantly already at the first visit and maintain positive results for up to one year.

In some selected patients, the study also shows a control MRI scan where it was possible to observe a reduction, or even disappearance, of the peri-lesional subchondral edema and, in one case, also a reduction of the chondral lesion.

Lipocell is a medical device able to purify, directly in the operating room, the patient’s adipose tissue, naturally rich in mesenchymal stem cells. The product thus processed, according to minimal manipulation requirements, is able to release molecules useful for repairing damaged tissue and modulate inflammation, restoring the homeostatic balance of the joints and slowing osteoarthritic progression.

We thank all authors of the work and in particular Dr. Gianluca Castellarin for the care and sharing of the paper, which is available for a consultation below.

Castellarin G, Mosca S, Micera G, Moroni A. Intra-articular administration of purified autologous adipose tissue for knee osteoarthritis treatment. Minerva Ortop Traumatol 2020;71:93-7. DOI: 10.23736/S0394-3410.20.03976-4

Lipocell Publication

Please note our latest publication in the Special Issue entitled “Advances in Regenerative Medicine and Tissue Engineering” by MDPI Processes magazine. In this last article, we characterized Lipocell from the cellular and histological point of view. The following paragraphs are technical hints dedicated to insiders; the general publican can jump to the conclusion of the article.

HOW MANY CELLS ARE THERE?

The mechanism of function of Lipocell technology is a dialysis membrane that separates the elements of a solution, in this case, lipoaspirate. The filter has a porosity equal to 50 µm that retains adipose tissue, but permeable to washing solution, blood, and excess oil. The mesenchymal stem cell (MSCs) count was performed by comparing the standard device with smaller filters (15 and 20 µm). Lipocell, on average, has 2-3 times more MSC than untreated fat. At the same time, no differences were found between the different filters, suggesting that a filter with lower porosity is not useful to retain more cells.

FROM RED TO YELLOW

Excess of blood and oil, in case of lipofilling (re-integration of adipose tissue into the patient for filling or regenerative purposes), can be a problem. These are waste residues, without recognized biological activity, which can cause inflammatory reactions. The 50 µm Lipocell filter can purify tissue from these elements more effectively and quickly than smaller filters or other methods.

A MORE CONSERVATIVE METHOD THAN CENTRIFUGATION

From a regulatory point of view, excessive manipulation of adipose tissue turns the product into an ATMP, which stands for Advanced Therapeutic Medicinal Product. Consequently, it should be subject to strict regulation that is not compatible with routine clinical practice. Cell culture, for example, substantially modifies the cellular product. The same can be said of enzymatic digestion or significant mechanical manipulation which, by altering the structure of the tissue, become more than minimal manipulation. In our article we have characterized the elements of the extracellular matrix through biochemical analysis and performed histologies to compare the Lipocell product with untreated and centrifuged fat. Lipocell maintains a tissue architecture fully comparable to native fat, while the centrifuged one shows a substantial alteration of the structure.

THE RINGER’S LACTATE

The procedure with Lipocell also involves the use of a washing solution. Results have shown that washing with Ringer’s Lactate (instead of saline) fully preserves the proliferative potential of MSCs. The mechanism of action behind this novelty requires further investigation. Still, a possible explanation may be that the adipose tissue cells, after liposuction, go into ischemic shock due to lack of oxygen (as they no longer have a vascular supply). In oxygen deficiency, the cells initiate anaerobic respiration, which is a less efficient way to produce energy, but the administration of lactate ion could compensate this reaction by restoring the Krebs cycle and thus improve cell survival.

REGENERATIVE MEDICINE FOR ALL

Lipocell is a medical device classified IIa for intra-operative processing of adipose tissue. The mechanism of function is based on a dialysis membrane, which, in combination with a washing step, can separate adipose tissue from waste elements such as excess wash solution, free oil, and blood. The final product is enriched with MSC with great regenerative potential (see our recent article: “Fat is beautiful”), with the advantage of being easily injectable and with a preserved tissue architecture that meets the most stringent regulatory requirements.

Monocytes treatment for hip OA – Case Report

The orthopaedic group led by Dr. Vincenzo Madonna at Humanitas Castelli in Bergamo has published a case report using our device Monocytes.

Regenerative medicine is useful for treating damaged tissues through a minimally invasive approach. In this way, it is possible to prevent major surgeries, or speed up recovery after surgery. When we talk about last-stage osteoarthritis, however, it is necessary to sacrifice the joint with a prosthesis and biological therapies are no longer useful. Nevertheless, cartilage often ages on both joint sides and when it’s time for the implantation of a prosthesis (ed. knee or hip, it is the same), regenerative medicine can be useful in the so-called “contralateral” joint, ie in the opposite side.

In this work, the clinical results of this therapeutic strategy emerge. Before treatment, the patient reported disability and lameness caused by the arthritic condition of her right hip, which was a candidate for prosthesis, but also continuous pain and limitation of mobility on the left side. The replaced hip (the right one) achieved the expected good results, but also the other joint treated (the left one) with Monocytes (ed. mononuclear cells from peripheral blood) showed total pain relief and excellent recovery of mobility, with a very high index of satisfaction from the patient.

Monocytes can restore joint homeostasis through the release of growth factors and inflammation mediators. Moreover, macrophages, which derive from the differentiation of monocytes, can recycle the oxidized elements of synovial fluid such as hyaluronic acid and lubricin, improving the metabolic and mechanical balance of the joint.

We thank all the authors of the work and in particular Dr. Francesca De Caro for the care and sharing of the work, which is available for a consultation below.

Francesca De Caro, Arcangelo Russo, Gabriele Cortina, Marco Collarile, Vincenzo Condello, Vincenzo Madonna. New Trends in Treatment of Osteoarthritis: “From Cells to Metal”. A Case Report of Simultaneous Different Approach to Bilateral Hip Osteoarthritis. Ann Case Report 2019, 11: 247. DOI: 10.29011/2574-7754/100247

Omar Sabry