The ethical and regulatory-compliant training and practice of regenerative surgery in the United States and abroad.

Regenerative surgery (RS) may be functionally defined as: the application of regenerative material and techniques such as live cells or cell-derived material with surgical methods to affect clinical therapy for disease or restore normal human function. A global review of RS as it relates to formal residency and fellowship medical education programs is provided in addition to the current state of post-graduate medical education. Due to the complex nature of starting materials (i.e. live cells or derived biologics), invariably ancillary staff versant in high complexity laboratory techniques will be required to support these novel clinical lines of service in the RS industry. Theoretical implications on both the development, training and credentialing of these unique professionals are preliminarily addressed. Although the current state of RS medical education has taken a predominantly conference and post-graduate approach across multiple surgical specialties, most new fields of surgery have developed under similar principles historically and should not be interpreted entirely as illegitimate or inappropriate.

Autologous fat transfer with in-situ mediation (AIM): a novel and compliant method of adult mesenchymal stem cell therapy.

BACKGROUND: In an attempt to engineer a regulatory compliant form of cell assisted lipotransfer in the U.S., the authors developed Autologous Fat Transfer with In-situ Mediation (AIM) for reconstruction of a refractory surgical scar. METHODS: This method incorporates use of accepted standard procedures like autologous fat grafting and intradermal injection of NB6 collagenase to release adipose stem cells from a naturally occurring high concentration stromal vascular fraction (SVF) fat graft. To prevent off-target effects of collagenase, a hyaluronic acid and serum deactivation barrier is placed circumferentially around the operative site. FINDINGS: This novel protocol was well tolerated by the patient and improved scar appearance, mobility and texture. Deepest scar contour defect correction was 80% and 77% at 4 and 12 weeks respectively. CONCLUSION: AIM appears to be a practical and viable option for scar reconstruction requiring small to moderate volume correction.

Isolated neck-lifting procedure: isolated stork lift.

BACKGROUND: Many patients desire cosmetic improvement of neck laxity when consulting with a plastic surgeon about their face. Neck laxity and loss of the cervicomental angle can be due to multiple components of aging such as skin quality/elasticity, loss of platysma muscle tone, and submental fat accumulation. Traditionally, the procedure of choice for patients with an aging lower face and neck is a cervicofacial rhytidectomy. However, occasionally, a patient wishes to have no other facial surgery than an improvement of their excessive skin of the anterior, lateral, and/or posterior neck. In other instances, a patient may present with having had a face/neck-lifting procedure that left objectionable vertical/diagonal lines at the lateral neck. In both these instances, a surgeon should consider an isolated stork lift (ISL) procedure. An ISL procedure avoids and/or corrects problematic vertical/diagonal lateral neck folds by "walking" the excess skin flaps around the posterior inferior occipital hairline bilaterally, bringing the flaps together at the lateral and posterior neck, which sometimes involves a midline posterior dart excision of the dog ear. A patient presenting with excessive skin of the neck (anterior, lateral, and/or posterior) and/or residual vertical/diagonal skin folds is an excellent candidate for the ISL. METHODS: The ISL procedure was performed on 273 patients over a 2-year period at The Morrow Institute. Patients were included if they had excessive skin of the anterior, lateral, and/or posterior neck and/or diagonal/vertical lateral bands and did not desire a full face-lifting procedure. Patients were excluded from this study if they would not accept having longer hair in order to cover the scar along the posterior inferior occipital hairline or a midline T-flap skin closure scar at the base of the posterior midline neck. Under a combination of local anesthesia and IV sedation, a postauricular face-lift incision was made that was extended in a circumoccipital fashion along the mastoid and posterior hairline to the midline nape of the neck. Long skin flaps were developed by dissecting the anterior neck from the mentum to the anterior clavicles, the lateral neck from the mastoid to the lateral clavicles, and the posterior neck from the hairline to the base of the nape of the neck, all with a combination of sharp and blunt dissection. Suspension sutures of the SMAS were placed at various strategic locations along the lateral neck in a superior posterior vector. The dog ears were walked posteriorly around the hairline, with final trimming at the midline nape using an A-to-T flap closure. The skin closure was affected by a combination of deep and superficial sutures as well as staples. No drains were used on any of the cases. RESULTS: Of the 273 patients (59 males and 214 females) who had the ISL, 240 rated their satisfaction with the results as very high, 21 rated it as high, and 12 rated it as some what satisfied. The average age of the patients was 58.7 years (range=45-79 years). There were two patients who needed a minimal amount of submental liposuction after the procedure. No patients had vertical/diagonal skin folds after this procedure. Five patients reported being slightly bothered by the appearance of the midline posterior scar for the first 6 months. Three of these cases involved hypertrophic scarring and were treated with intralesional triamcinolone suspension 40 mg per cc dilution; doses ranged from 20 to 40 mg per session and no more than two sessions were required. All five cases rated their scar appearance after 6 months to be acceptable. All of the remaining 268 patients reported that the final posterior scar was virtually undetectable. Ten patients needed scar revision for secondary widening of the scar at various locations of the lateral, posterior, and or nape of the neck. There were no other significant complications. Most patients were satisfied with their cosmetic result 2 years after their operation. CONCLUSION: An ISL procedure provides excellent lifting of the anterior, lateral, and posterior neck without the resulting postoperative sequelae of vertical/diagonal lines, and it is especially indicated for the patient who has markedly excessive skin in those areas and does not want to undergo a lower face-lift procedure at the same time. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The post-adjustable gastric band abdominoplasty.

Serious complications associated with post-laparoscopic adjustable gastric band (LAGB) abdominoplasty have been reported in the medical literature. Furthermore, others have noted aesthetic problems with closure of the umbilicus due to apparatus port proximity. Currently, no clinical protocol or formal industry guidance for LAGB apparatus management during abdominoplasty is available in the medical literature. In this article, the authors describe their procedure for safe LAGB apparatus management during abdominoplasty and illustrate key surgical principles by presenting unique cases from their series of 20 patients treated with this technique.

Clinical use of Dieletrophoresis separation for live Adipose derived stem cells.

BACKGROUND: Microelectrode dieletrophoresis capture of live cells has been explored in animal and cellular models ex-vivo. Currently, there is no clinical data available regarding the safety and efficacy of dielectrophoresis (DEP) buffers and microcurrent manipulation in humans, despite copious pre-clinical studies suggesting its safety. The purpose of this study was to determine if DEP isolation of SVF using minimal manipulation methods is safe and efficacious for use in humans using the hand lipotransfer model. METHODS: Autologous stromal vascular fraction cells (SVF) were obtained from lipoaspirate by collagenase digestion and centrifugation. The final mixture of live and dead cells was further processed using a custom DEP microelectrode array and microcurrent generator to isolate only live nucleated cells. Lipotransfer was completed using fat graft enhanced with either standard processed SVF (control) versus DEP filtered SVF (experimental). Spectral photography, ultrasound and biometric measurements were obtained at post operatively days 1, 4, 7, 14, 30, 60 and 90. RESULTS: The DEP filter was capable of increasing SVF viability counts from 74.3 ± 2.0% to 94.7 ± 2.1%. Surrogate markers of inflammation (temperature, soft tissue swelling, pain and diminished range of motion) were more profound on the control hand. Clinical improvement in hand appearance was appreciated in both hands, though the control hand exclusively sustained late phase erosive skin breaks on post operative day 7. No skin breaks were appreciated on the DEP-SVF treated hand. Early fat engraftment failure was noted on the control hand thenar web space at 3 months post surgery. DISCUSSION: No immediate hypersensitivity or adverse reaction was appreciated with the DEP-SVF treated hand. In fact, the control hand experienced skin disruption and mild superficial cellulitis, whereas the experimental hand did not experience this complication, suggesting a possible "protective" effect with DEP filtered SVF. Late ultrasound survey revealed larger and more frequent formation of oil cysts in the control hand, also suggesting greater risk of engraftment failure with standard lipotransfer. CONCLUSION: Clinical DEP appears safe and efficacious for human use. The DEP microelectrode array was found to be versatile and robust in efficiently isolating live SVF cells from dead cells and cellular debris in a time sensitive clinical setting.