Tag: Lipogems®

Refractory Shoulder Pain with Osteoarthritis, and Rotator Cuff Tear, Treated With Micro-Fragmented Adipose Tissue

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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.

Non-Responding Knee Pain with Osteoarthritis, Meniscus and Ligament Tears Treated with Ultrasound Guided Autologous, Micro-Fragmented and Minimally Manipulated Adipose Tissue

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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.

Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance

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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.

Injection of autologous micro-fragmented adipose tissue for the treatment of post-traumatic degenerative lesion of knee cartilage: a case report

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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.

Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance

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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.

Non-Responsive Shoulder Pain with Osteoarthritis and Rotator Cuff Tears Treated With Autologous Micro-Fragmented and Minimally Manipulated Adipose Tissue under Continuous Ultrasound Guidance

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R. Striano, RMSK, N. Bilbool, MD, G. Malanga, MD

Chronic shoulder pain due to osteoarthritis is often associated with rotator cuff pathology and affects a large portion of the adult population. It results in substantial pain and impairments of daily functions, such as loss of range of motion, inability to elevate the arm, increasing pain with activity and gradual worsening over time, thus limiting activity and quality of life. Patients are often refractory to current nonoperative treatments and often require total shoulder arthroplasty.

 

Non-Responsive Shoulder Pain with Osteoarthritis and Rotator Cuff Tears Treated With Autologous, Micro-Fragmented and Minimally Manipulated Adipose Tissue Under Continuous Ultrasound Guidance

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R.Striano, G. Malanga, J. Bowen, N. Bilbool, K. Azatullah, J. Hilado

ABSTRACT

Background: Orthopedic pain from osteoarthritis (OA) and rotator cuff disease affect a large portion of the adult population. The result is pain, reduced range of motion, impairment in activities of daily living and a worsening quality of life. Currently, there are limited treatments if non-operative care fails. In this context, the autologous fat graft is gaining interest. Fat is readily accessible and simple to harvest, to provide volume, cushion, structural support, repair and replacement of damaged tissues. In addition, fat graft is a heterogeneous mix of cellular and non-cellular elements that produce trophic cascades.

Objective: To study the safety and benefits of using an autologous, minimally manipulated adipose tissue graft for treating degenerative shoulder pathology with pain having failed conventional care.

 Study description: To remove variables in assessing outcomes of the fat graft exclusively, no other biologics or pharmacologics were introduced with the treatment. 18 subjects (19 shoulders) reached one-year follow-up, which was part of an ongoing IRB study approved by IRCM (Institute of Regenerative and Cellular Medicine).  Two subjects were lost to follow up prior to one year.  The patients were ages: 39 – 89 with moderate to advanced degeneration. Tears (all confirmed on MRI): Glenohumeral Osteoarthritis: Severe n=10, moderate n=8. Acromio-clavicular arthrosis: n=8. Rotator Cuff: Supraspinatus: Full thickness tears n=8, complete tear n=2, partial thickness tears n=7, tendinosis n=8, fatty atrophy n=5. Infraspinatus: Tendinosis n=6, full thickness tear n=1.  Subscapularis: Tendinosis n=4, intra-substance tear n=1. Labrum: Tear n=7. Bicep tendon: Tendinosis n=1, partial thickness tear n=4.

Material and Methods: An autologous, mircofragmented, fat graft was obtained using a minimal manipulation technology in a closed system, without the addition of enzymes or other additives.

The graft was injected in 1cc aliquots under continuous ultrasound guidance, into each joint and/or each tendon / soft tissue defect.  Clinical outcomes are shown in Fig. 1-7.

 Results: Other than pain consistent with multiple injections, no adverse events were reported. The improvement of the symptoms occurred within a few days after treatment and all measured scores (symptoms, signs, and function) showed significant improvement to one-year follow-up (NPS p<0.0001, ASES p<0.0002, Constant p< 0.0006. Figures 1-7).

 Conclusion: Although more investigation is needed, these results show promise where other methods have failed. The injection of autologous, micro-fragmented, and minimally manipulated adipose tissue appears very effective in patients with shoulder disease that failed conventional treatments.