The NEXT BIG WAVE IN MEDICINE 
This is THE NEXT BIG WAVE; the science and administration of regenerative medicine 
and THIS IS OUR MISSION

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    Richard D Striano1*, Gerard A Malanga2, Norma Bilbool3, Khatira Azatullah4

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    Abstract

    Background: Chronic shoulder pain and rotator cuff abnormalities affect a large portion of the population and result in substantial impairments and loss of useful functions, thus affecting patient quality of life. One of the most common causes of shoulder pain in the adult population is osteoarthritis. It is the third most prevalent musculoskeletal disorder after low back and neck pain. If current standard non-operative methods fail, there are few viable options available other than shoulder replacement surgery. Recently biological treatments using adult stem cell treatments, mesenchymal stem cells (MSC’s) have been shown to have potential benefits in orthopedic applications. One such source of regenerative cellular tissue is adipose, which is known to be a robust source of stem cells. Adipose tissue is readily accessible, easily harvested and few complications have been reported. This study embarks on reporting the safety, efficacy and long term benefits from ultrasound guided injection of an autologous, minimally manipulated, microfragmented adipose tissue.

    Materials and Methods: Material and Methods: An explanation of the treatment was provided and informed consent obtained. The micro-fragmented adipose tissue was obtained with minimal manipulation using Lipogems® (Lipogems USA, Atlanta Ga.) a closed system using normal saline cleansing, mild mechanical separation of waste products and reduction filters. The system provides a lipoaspirate without the addition of enzymes or any other additives. The final product consists of adipose tissue clusters with preserved vascular stromal niche of approximately 500 microns. The injections were delivered into the joint and each soft tissue abnormality under direct ultrasound guidance as was found to be clinically relevant. Numeric pain scores and The American Shoulder and Elbow Surgeons Score (ASES) were collected immediately following treatment, and at weeks 1 and 5, months 3, 6 and 12.

    Results: Significant improvement was noted through all time points to one year. Outcomes assessed immediately following treatment, at weeks 1 and 5, months 3, 6 and 12 by Numerical Pain Scale (NPS) and The American Shoulder and Elbow Surgeons Score (ASES). NPS (p<0.00008), ASES (p< 0.00017). The average improvement of NPS was from 7.5 to 3.6 at one year. The average ASES from 33.7 to 69.2 at one year (0-100 scale 100 perfect function). No post procedural complications or serious adverse events were reported.

    Conclusions: While the limitations of this study are a low number of subjects and not a randomized controlled trial, it is noteworthy that most published studies are shorter term follow up 3-6 months. The results from this study demonstrate significant improvements in pain, function and quality of life as represented by positive outcomes in all measured scores through twelve months.

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    G. Cattaneo1* , A. De Caro1, F. Napoli1, D. Chiapale2, P. Trada2 and A. Camera1

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    Abstract

    Background: The social impact of degenerative diseases is steadily increasing, because of the continued rise in the mean age of the active population. Articular cartilage lesions are generally associated with disability and symptoms such as joint pain and reduced function, and remain a challenge for the orthopaedic surgeon. Several non-invasive solution have been proposed, but the results achieved to date are far from being completely satisfactory. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells, have been developed. Among the many sources, the adipose tissue is nowadays considered one of the smartest, due to its abundance and easy access. The aim of this retrospective study is to explore whether patients affected by symptomatic knee osteoarthritis treated with micro-fragmented adipose tissue associated with a chondral shaving procedure experience an improvement in symptoms and function.

    Methods: Thirty-eight patients affected by symptomatic knee osteoarthritis were treated in 2015 with an arthroscopic procedure associated with an injection of autologous and micro-fragmented adipose tissue. Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system. Clinical outcomes were determined at 1, 3, 6, and 12 months follow-up using Knee Injury and Osteoarthritis Outcome Score questionnaire and direct physical examination. Safety of the procedure, recording type and incidence of any adverse event, was also assessed.

    Results: A steady and statistically significant improvement of all the clinical scores from pre-operative evaluation to 1, 3, 6, and 12 months follow-up was observed, with KOOS sport and quality of life being the most improved scores. On average, 92% of the patients clinically improved and 100% of them were satisfied with the treatment. No adverse events nor relevant complications were recorded.

    Conclusion: The result of the study pointed to micro-fragmented adipose tissue as a safe and beneficial adjuvant in the surgical treatment of degenerative knee chondropathy. The procedure is simple, sustainable, quick, minimally invasive, one-step, and safe. After one year, the results are very satisfactory and promising. A longer follow-up is needed to draw definitive conclusions and enlarge the indications.

    Trial registration: Registered at clinicaltrials.gov as NCT03527693 on 27 April 2018 (retrospectively registered).

     

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    A. Russo1* , V. Condello1, V. Madonna1, M. Guerriero2 and C. Zorzi1

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    Abstract

    Background: Chondral lesions of the knee represent a challenge for the orthopaedic surgeon. Several treatments have been proposed with variable success rate. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells, have shown promising results. The adipose tissue is a good source of these naturally occurring regenerative cells, due to its abundance and easy access. In addition, it can be used to provide cushioning and filling of structural defects. The 1-year safety and outcome of a single intra-articular injection of autologous and micro-fragmented adipose tissue in 30 patients affected by diffuse degenerative chondral lesions was evaluated.

    Methods: Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system. The safety of the procedure was evaluated by recording type and incidence of any adverse event. The clinical outcomes were determined using the KOOS, IKDC-subjective, Tegner Lysholm Knee, and VAS pain scales taken pre-operatively and at 12 months follow-up. A level of at least 10 points of improvement in the scores has been selected as cut-off representing a clinically significant difference.

    Results: No relevant complications nor clinical worsening were recorded. A total median improvement of 20 points has been observed in IKDC-subjective and total KOOS, and a higher percentage of success was found in VAS pain and Tegner Lysholm Knee, where the total median improvement was 24 and 31 points, respectively.

    Conclusion: The results of this study show the safety and feasibility of using autologous and micro-fragmented adipose tissue in patients affected by diffuse degenerative chondral lesions. The technique is safe, minimally invasive, simple, one-step, with low percentage of complications, and compliant with the regulatory panorama.

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    Damir Hudetz 1,2,3,*, Igor Borić 1,4,5, Eduard Rod 1, Željko Jeleč 1, Andrej Radić 1, Trpimir Vrdoljak
    1,2, Andrea Skelin 1,6, Gordan Lauc 6,7, Irena Trbojević-Akmačić 6, Mihovil Plečko 8, Ozren Polašek
    4,7 and Dragan Primorac 1,3,4,9,10,11,12,*

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    Abstract: Osteoarthritis (OA) is one of the leading musculoskeletal disorders in the adult population. It is associated with cartilage damage triggered by the deterioration of the extracellular matrix tissue. The present study explores the effect of intra-articular injection of autologous microfragmented adipose tissue to host chondrocytes and cartilage proteoglycans in patients with knee OA. A prospective, non-randomized, interventional, single-center, open-label clinical trial was conducted from January 2016 to April 2017. A total of 17 patients were enrolled in the study, and 32 knees with osteoarthritis were assessed. Surgical intervention (lipoaspiration) followed by tissue processing and intra-articular injection of the final microfragmented adipose tissue product into the affected knee(s) was performed in all patients. Patients were assessed for visual analogue scale (VAS), delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) and immunoglobulin G (IgG) glycans at the baseline, three, six and 12 months after the treatment. Magnetic resonance sequence in dGEMRIC due to infiltration of the anionic, negatively charged contrast gadopentetate dimeglumine (Gd-DTPA2−) into the cartilage indicated that the contents of cartilage glycosaminoglycans significantly increased in specific areas of the treated knee joint. In addition, dGEMRIC consequently reflected subsequent changes in the mechanical axis of the lower extremities. The results of our study indicate that the use of autologous and microfragmented adipose tissue in patients with knee OA (measured by dGEMRIC MRI) increased glycosaminoglycan (GAG) content in hyaline cartilage, which is in line with observed VAS and clinical results.

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    Richard David Striano, Valeria Battista, Norma Bilboo

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    Abstract

    Background: Chronic knee pain from advanced osteoarthritis is often associated with tears in the fibro-cartilaginous meniscus and cruciate ligaments. The result is substantial pain and impairments and loss of daily function, thus limiting activity and quality of life. These often include pain, loss of range of 116 motion, inability to elevate the leg, pain increased with activity and gradual worsening over time. This represents a challenging clinical picture for which few non-surgical options are available. Most patients failing to respond to current methods of care are offered arthroplasty. Current therapies are focused on the relief of the symptoms but cannot repair the damage nor stop the degenerative process.

    Objective: This is a case study of the first subject in a continuing IRB to reach a 2.5 year end-point. Our intention was to investigate the potential benefits of using autologous, minimally manipulated fat graft in subjects with advanced osteoarthritis and meniscus pathology who had failed to obtain benefit from previous, standards of care.

    Study description: 73 YO male, end stage bone-on-bone right knee pain. First subject to reach the 2 1/2 year follow up after Lipogems® precision ultrasound guided injections.

    Material and Methods: Micro-fragmented fat was obtained using a minimal manipulation technology in a closed system, Lipogems®, without the addition of enzymes or other additives. Fat graft was injected under continuous ultrasound guidance.

    Results: VAS pain, KOOS function, range of motion and quadriceps strength improved after treatment.

    Conclusion: Autologous, micronized, and minimally manipulated adipose tissue resulted in significant improvement in pain, function and quality of life. No adverse events were reported.

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    R.D. Striano, H. Chen, N. Bilbool, K. Azatullah, J. Hilado, K. Horan

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    ABSTRACT

    Background: Adipose tissue has gained increased interest in the medical and scientific community over the last few years as a source for ortho-biologic therapies. It is readily accessible and simple to harvest. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells.

    Objectives: To evaluate the potential benefits of injecting a severely arthritic knee with concurrent meniscal disease with micro-fragmented non-digested adipose tissue using a novel technique by obtaining minimally manipulated and micronized fat tissue with intact stromal vascular niches harboring regenerative cellular elements. The case is non-responsive knee pain with osteoarthritis and concurrent meniscal disease.

    Case Description: This case is the first of a 100- subject IRB study approved by IRCM. The patient is a 59-year-old male with severe knee pain who has failed a multitude of treatments, including arthroscopic meniscal surgery. The MRI prior to surgery revealed evidence of osteoarthritis, medial meniscal tear, and chondromalacia patella. The patient was followed for 6 months, and will continue to be followed for two years.

    Materials and Methods: Micro-fragmented fat was obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any other additives. The final product consisted of micronized fat tissue yielding fat clusters with preserved vascular stroma of about 500 microns with intact stromal vascular niches and harboring regenerative cellular elements. In this treatment protocol, the micronized fat was injected with a 22- gauge needle under continuous ultrasound guidance into the joint and filling the hypoechoic defects in the medial meniscus. No other biological or pharmacological agents were used in combination with the micronized fat. Outcomes were measured immediately following the treatment, 24 hours, 1 week, 5 weeks, 3 months, 6 months and 1 year after the injections. At 6 months, a repeat MRI of the joint was performed.

    Results: One year after the treatment, we found improvement in all measured scores. VAS pain score on a 1-10 scale, with 10 being worse, improved from 8 to 0; the KOOS (Knee Injury and Osteoarthritis Score) outcome, with a score of 100 being perfect, improved from 45 to 92.9. MRIs taken at 6 months post-treatment, revealed improved signal and thickness of the cartilaginous tissue over the medial femoral condyle, with a widened joint space. Radiologist initial measure of articular cartilage reported as 0.75 mm and at 6 months reported as 1.5 mm.

    Conclusion: The injection of autologous microfragmented adipose tissue obtained with the new technique, Lipogems® in the case of non-responsive knee pain appears to be a promising and viable treatment. Due to the arthroscopic surgery taking place following the original MRI and prior to the treatment with micronized fat, the change in the meniscus after 6 months is not comparable. Further studies are underway.

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    M. Franceschini, C. Castellaneta, G. Mineo

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    ABSTRACT

    Background: The chondral lesion of the knee represents a challenge for the orthopedic surgeon because of the limited regenerative properties of the affected tissue. A variety of treatments has been proposed with variable success rates. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells (MSCs), seem to have promising results when applied in the context of joint degeneration, and an ideal source could be the adipose tissue, due to its abundance, the easy access, and the simple isolation procedures.

    Objective: To evaluate the potential benefits of injecting autologous, micro-fragmented, and minimally manipulated adipose tissue (Lipogems®) in a severe case of a multi-operated cartilage degeneration.

    Case description: The patient is a 33 years-old man, semi-professional snowboarder, with a knee trauma due to a ski fall who has failed a number of treatments. The patient was injected with Lipogems® and followed up for 30 months.

    Patients and Methods: Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any other additives.

    Results: After a first period of worsening of pain, symptoms got progressively better, and the pain completely disappeared in 6 weeks. The Oxford Knee Score at 12 weeks improved from 36 (baseline) to 46. The clinical improvement was confirmed by the MRI at 12 months. Thirty months after Lipogems® treatment the patient was able to ski with no pain and no restrictions.

    Conclusion: Although this is a single case report, our results suggest that the autologous, micro-fragmented and minimally manipulated adipose tissue injected in a joint affected by a chondral lesion provides support and potential healing, improves joint functionality and determines pain relief.

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    Riccardo D’Ambrosi, Cristian Indino, Camilla Maccario, Luigi Manzi, Federico Giuseppe Usuelli

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    Abstract:

    In recent years, regenerative techniques have been increasingly studied and used to treat osteochondral lesions of the talus. In particular, several studies have focused their attention on mesenchymal stem cells derived from adipose tissue. Adipose-derived stem cells (ADSCs) exhibit morphological characteristics and properties similar to other mesenchymal cells, and are able to differentiate into several cellular lines. Moreover, these cells are also widely available in the subcutaneous tissue, representing 10 – 30% of the normal body weight, with a concentration of 5,000 cells per gram of tissue. In the presented technique, the first step involves harvesting ADSCs from the abdomen and a process of microfracture and purification; next, the surgical procedure is performed entirely arthroscopically, with less soft tissue dissection, better joint visualization, and a faster recovery compared with standard open procedures. Arthroscopy is characterized by a first phase in which the lesion is identified, isolated, and prepared with microperforations; the second step, performed dry, involves injection of adipose tissue at the level of the lesion. Between January 2016 and September 2016, four patients underwent arthroscopic treatment of osteochondral lesion of the talus with microfractured and purified adipose tissue. All patients reported clinical improvement six months after surgery with no reported complications. Functional scores at the latest follow-up are encouraging and confirm that the technique provides reliable pain relief and improvements in patients with osteochondral lesion of the talus.

    Video Link:

    The video component of this article can be found at https://www.jove.com/video/56395/

    Introduction:

    Arthroscopy is the gold standard for the treatment of osteochondral lesions of the talus (OLTs) with the aim of pain relief, restoring functionality, and improving quality of life, especially in young and active patients. Currently, arthroscopic techniques can be classified in three ways. The reparative technique stimulates cells derived from bone marrow through a debridement and microperforations at the level of lesion. The reconstructive technique replaces the lesion using an autologous or heterologous ostechondral graft. The regenerative technique exploits the ability of multipotent cells to differentiate and replicate to reconstruct the damaged tissue1,2,3,4,5,6.

    In recent years, regenerative techniques have been the subject of numerous in vitro and in vivo studies for the treatment of OLTs, and particularly mesenchymal stem cells derived from adipose tissue (ADSCs)7,8,9. These mesenchymal stem cells exhibit morphological and functional characteristics similar to other multipotent cells, isolated from other tissues; they also have the ability to differentiate into several and different cellular lines both in vitro and in vivo10,11,12,13. The focus on research regarding these cells is mainly due to their localization, in fact they represent from 10% to 30% of normal body weight with a concentration of 5,000 cells per gram of tissue13,14. On the other hand, a factor that limits the use of these cells is related to their handling during laboratory procedures. The lipoaspirate containing aggregates of adipocytes, collagen fibers, and normal vascular components is enzymatically processed with collagen A type I, and subjected to hemolysis before culture. The aim here is to describe the protocol for the treatment of osteochondral lesions of the talus using microfractured and purified adipose tissue.

    Protocol:

    All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee, and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

     

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    Richard David Striano, Valeria Battista, Norma Bilboo

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    Background: Chronic knee pain from advanced osteoarthritis is often associated with tears in the fibro-cartilaginous meniscus and cruciate ligaments. The result is substantial pain and impairments and loss of daily function, thus limiting activity and quality of life. These often include pain, loss of range of 116 motion, inability to elevate the leg, pain increased with activity and gradual worsening over time. This represents a challenging clinical picture for which few non-surgical options are available. Most patients failing to respond to current methods of care are offered arthroplasty. Current therapies are focused on the relief of the symptoms but cannot repair the damage nor stop the degenerative process.
    Objective: This is a case study of the first subject in a continuing IRB to reach a 2.5 year end-point. Our intention was to investigate the potential benefits of using autologous, minimally manipulated fat graft in subjects with advanced osteoarthritis and meniscus pathology who had failed to obtain benefit from previous, standards of care. Study description: 73 YO male, end stage bone-on-bone right knee pain. First subject to reach the 2 1/2 year follow up after Lipogems® precision ultrasound guided injections.
    Material and Methods: Micro-fragmented fat was obtained using a minimal manipulation technology in a closed system, Lipogems®, without the addition of enzymes or other additives. Fat graft was injected under continuous ultrasound guidance. Results: VAS pain, KOOS function, range of motion and quadriceps strength improved after treatment.
    Conclusion: Autologous, micronized, and minimally manipulated adipose tissue resulted in significant improvement in pain, function and quality of life. No adverse events were reported.
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    Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance

    R.Striano, H. Chen, N. Bilbool, K. Azatullah, J. Hilado, K. Horan

    The use of autologous adipose has gained interest as a source for ortho-biologic therapies. Fat is readily accessible and simple to harvest. This adipose can be used to provide cushion and filling in of structural defects. Adipose has been shown to have an abundance of regenerative perivascular cells.

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