Search Results (26)

Androgenetic alopecia (AGA) is a prevalent, multifactorial hair disorder affecting a substantial portion of both males and females, with significant psychosocial consequences. Over the past decade, regenerative medicine has reshaped AGA treatment, offering biologically driven alternatives to conventional pharmacological and surgical therapies. Among these, Autologous Micrografting Technology (AMT) (Regenera Activa^® by Rigenera^® Technology, Barcelona, Spain) emerged 10 years ago as a notable innovation leveraging the body’s intrinsic regenerative potential through micrografts derived from a healthy scalp tissue. This review provides a comprehensive overview of the pathophysiology of AGA—including genetic, hormonal, and inflammatory contributors—and evaluates the clinical efficacy, safety, and mechanistic basis of AMT in comparison with other regenerative strategies such as platelet-rich plasma, adipose-derived mesenchymal stem cells, and exosome-based treatments. Clinical studies demonstrate that AMT yields significant short-term improvements in hair density and thickness with favorable safety outcomes. Moreover, advancements in device technology and treatment protocols have enhanced consistency and reproducibility. As multimodal and personalized approaches gain traction in hair restoration, AMT is a minimally invasive point-of-care procedure within the evolving regenerative landscape. Future studies are warranted to optimize treatment algorithms, extend follow-up data, better define patient selection criteria for maximizing outcomes with AMT, and expand the indication of autologous micrografting technology. Full article

Adipose tissue micrografts (ATM) and dermis micrografts (DMG) have emerged as promising autologous therapies in regenerative wound care, leveraging mechanically disaggregated cell–matrix constructs to modulate the wound microenvironment and promote tissue repair. This scoping review systematically analyzed clinical studies investigating ATMs and DMGs in acute and chronic wounds. Eight studies, comprising randomized controlled trials, observational studies, and case series, were identified, involving diverse wound types such as burns, ulcers, surgical dehiscence, and posttraumatic defects. All interventions utilized mechanical disaggregation (Rigenera^® system) to produce micrografts, which were applied via perilesional injection, scaffold-assisted delivery, or topical administration. Outcomes consistently demonstrated accelerated re-epithelialization, enhanced angiogenesis, improved scar remodeling, and low complication rates. In select studies, micrografts were combined with platelet-rich fibrin or stromal vascular fraction, suggesting potential synergistic effects. While one randomized trial showed superior healing outcomes with DMGs over collagen scaffolds, others yielded mixed results, likely reflecting heterogeneity in methodology and outcome measures. Overall, the available clinical evidence supports the safety, feasibility, and biological activity of micrograft-based therapies. However, larger, standardized, and mechanistically driven studies are required to validate their efficacy and define optimal protocols across wound etiologies. Full article

Background/Objectives: Atrophic nonunion presents a significant challenge in hand surgery, often resulting in chronic pain and functional disability. Traditional surgical treatments such as bone grafting and internal fixation may be insufficient. This study evaluates the feasibility, safety, and preliminary effectiveness of a regenerative-first surgical protocol that combines autologous bone micro-grafts with a fresh human amniotic membrane to create a biologically active regenerative chamber. Methods: A total of 8 patients (6 males, 2 females; age range: 22–56 years) with an atrophic nonunion of metacarpals and phalanges were treated using a regenerative-first surgical approach. Autologous bone was harvested from the iliac crest and mechanically disaggregated via Rigenera^® technology to obtain micro-grafts enriched with osteoprogenitor cells and extracellular matrix fragments. These were applied to the bone defect and wrapped in a fresh amniotic membrane, creating a biologically active chamber. Fixation was achieved using low-profile plates or screws, and all patients underwent early protected mobilization. Results: Radiographic consolidation was achieved in all patients within 2 months postoperatively. Functional outcomes at final follow-up demonstrated excellent or good results in Total Active Motion (TAM), with grip and pinch strength within normative ranges and minimal residual pain. Conclusions: This preliminary series suggests that combining autologous bone micro-grafts with an amniotic membrane in a regenerative surgical protocol is a promising strategy for managing atrophic nonunion in the hand. The approach was associated with rapid consolidation and excellent functional recovery. Further research with larger, controlled cohorts is warranted to validate efficacy and define standardized indications and techniques. Full article

The gold standards for coverage of wounds that cannot be primarily closed are full thickness skin grafts (FTSGs) and split thickness skins graft (STSGs). FTSGs harvest sites generally require primary closure, which limits availability, especially when treating larger wounds. STSGs have many shortcomings, including donor site morbidity. Fractional autologous skin replacement can be utilized in conjunction with or in lieu of STSGs to both improve graft outcomes of large wounds and to decrease donor site morbidity. Skin can be mechanically or chemically fractionated. Fractionated skin can be advantageous, as adnexal structures provide additional functionality without donor site morbidity. In this review, we will discuss current and emerging techniques in fractional skin replacement. Full article

Osteoarthritis (OA) is one of the most common joint diseases worldwide, predominantly present in elderly people. Being a major source of pain for patients, it is debilitating and leads inevitably to a reduction in quality of life. The management of OA needs a personalized and multidimensional approach, resulting in the emergence of new regenerative and non-invasive methods, such as the use of micrografts. In this pilot study, Rigenera^® Technology was employed to obtain micrografts of cartilage tissue to be injected into the knees of 10 patients with osteoarthritic pain. To assess the efficacy of the treatment concerning pain reduction at this site, patients were asked to complete KOOS and WOMAC questionnaire and a VAS test before and after the procedure. The results presented in this article show how Rigenera^® treatment can potentially improve OA symptoms, alleviating pain in patients. Full article

Osteoarthritis (OA) is the most common complex musculoskeletal disorder, resulting from the degeneration of the articular cartilage and characterized by joint pain and dysfunction that culminate in progressive articular cartilage loss. We present our experience in the management of hip and knee OA by means of the intra-articular injection of fat micrograft, describing our approach, which was developed from the belief in the powerful reparative effect of autologous fat graft on damaged tissue, as well as its natural lubricating effect on the joints. Inclusion criteria were as follows: men and women, aged 20 to 80 years, that referred articular pain of the hips and/or knees, showing initial-stage degenerative OA. From October 2018 to July 2023, a total of 250 patients underwent treatment with the Sefficare^® device (SEFFILINE srl, Bologna, Italy). The Superficial Enhanced Fluid Fat Injection device was used to perform autologous regenerative treatments in a safe, standardized, easy, and effective way on 160 women, 64%, and 90 men, 36%. A total of 190 procedures (76%) involved the knees, with 20 patients who were bilaterally treated, while 60 procedures, all unilateral, involved the hips (24%). The mean age at treatment was 52.4 years. Before treatment, each patient had undergone X-rays and Magnetic Resonance Imaging (MRI) of the painful hip/knee to evaluate and grade the articular OA. Postoperatively, each patient was assessed after one, three, six, and twelve months. The donor site postoperative course was uneventful other than minimal discomfort. Clinically, the ROM (range of motion) of the treated knee/hip increased an average of 10 degrees 3 months after treatment, but the stiffness was reduced, as reported by the patients. The VAS (Visual Analog Scale) was submitted at 3, 6, and 12 months, demonstrating a progressive reduction of pain, with the best score obtained at six months postoperatively. In total, 85% of patients were satisfied one year after treatment, with a considerable improvement in pain and quality of life. The satisfactory outcome of this minimally invasive procedure indicates that the intra-articular injection of fat micrograft can replace or considerably delay the need for the classical major joint replacement surgery, thanks to its impact on the quality of life of patients and financial cost. Full article

Background: The study aimed to examine the impact of stem cell treatment on quality of life (QoL) and sexual functioning in women with androgenetic alopecia (AGA). Methods: Twenty-three women underwent a single session of autologous cellular micrografts (ACMs). The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) and Female Sexual Function Index (FSFI) were used before and after 6 months. Results: The AGA severity decreased by an average of 1 point on the Ludwig scale (p = 0.004) after treatment. FSFI scores indicated sexual dysfunction in over half of the women at baseline, but they improved significantly post-treatment for arousal [median (IQR): 4.8 (1.5) vs. 5.10 (0.9); p = 0.035] and satisfaction [4.4 (1.4) vs. 4.8 (1.8); p = 0.025]. QoL scores improved after treatment in psychological health (57.96 ± 19.0 vs. 69.35 ± 14.0; p = 0.031) and environment (72.96 ± 13.4 vs. 81.09 ± 12.6; p = 0.007), but not in physical health and social relationships. No associations were found between the WHOQOL-BREF or FSFI domains versus age and AGA severity. Conclusions: AGA reduces QoL and impacts sexual functioning in women with AGA. The high treatment burden arises from the chronic and progressive nature of AGA, coupled with limited treatment effectiveness. Effective treatments for AGA, like ACM, are urgently needed to enhance patient-reported outcomes along with clinical results. Full article

Background: Androgenetic alopecia (AGA) is the most common form of alopecia, but treatment options are limited. This study evaluated clinical improvement in hair condition in women with AGA six months after a single injection of autologous cell micrografts (ACMs) containing hair follicle stem cells and dermal papilla cells. Methods: Twenty-three women with clinically and dermoscopy-confirmed AGA were included. Five 2.5 mm punch biopsies were taken from the skin of each patient with the Regenera device. The cell suspension was prepared with the Rigeneracons device and then injected into the hormone-dependent hairy zone of the scalp. Results: A significant improvement was observed on the visual analog scale (VAS) when comparing pre- and post-procedure photos (p < 0.001). The change in VAS scores was moderately negatively correlated with baseline ferritin concentration and positively with iron concentration. Improved outcomes were associated with higher baseline levels of sex hormone-binding globulin and 17α-hydroxyprogesterone. Neither testosterone nor DHT showed a significant correlation with VAS scores. Conclusions: The ACM procedure was shown to be both safe and effective, yielding satisfying results six months after a single treatment session. Future investigations should aim to gather evidence that enables the development of a cost-effective approach while minimizing treatment burden and costs. Full article

Autologous micrografting technology (AMT^®) involves the use of autologous micrografts to stimulate/enhance the repair of damaged tissue. This study assessed the efficacy and safety of the AMT^® procedure in patients with early stages of knee osteoarthritis. Briefly, the AMT^® procedure involved extraction of auricular cartilage, disaggregation using the Rigeneracons^® SRT in 4.0 mL of saline solution, and injection of the disaggregated micrografts into the external femorotibial compartment area of the affected knee. Ten patients (4 men, 6 women; age range: 37–84 years) were included in the study. In all patients, there was a steady improvement in knee instability, pain, swelling, mechanical locking, stair climbing, and squatting at 1- and 6-months post-procedure. Improvement in mobility was observed as early as 3 weeks post-procedure in 2 patients. Significant improvements were seen in mean scores of all five subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS [KOOS symptoms, KOOS pain, KOOS ADL, KOOS sport and recreation, and KOOS quality-of-life]) between pre-procedure and 1- and 6-months post-procedure (all p ≤ 0.05). Autologous auricular cartilage micrografts obtained by AMT^® procedure (using Rigenera^® technology) is an effective and safe protocol in the treatment of early stage knee osteoarthritis. These encouraging findings need to be validated in a larger patient population and in a randomized clinical trial (RCT). Full article

Successful treatments for acute and chronic skin wounds remain challenging. The goal of this proof-of-concept study was to assess the technical feasibility and safety of a novel wound treatment solution, FastSkin^®, in a pig model. FastSkin^® was prepared from skin micrografts patterned in blood using acoustic waves. Upon coagulation, the graft was transferred on a silicone sheet and placed on wounds. Six full-thickness wounds were created at the back of two pigs and treated with either FastSkin^®, split-thickness skin graft (positive control), a gauze coverage (negative control, NC1), or blood patterned without micrografts (negative control, NC2). Silicone sheets were removed after 7, 14, and 21 days. Wound healing was monitored for six weeks and evaluated macroscopically for re-epithelialization and morphometrically for residual wound area and wound contraction. Tissue regeneration was assessed with histology after six weeks. Re-epithelialization was faster in wounds covered with FastSkin^® treatments compared to NC2 and in NC2 compared to NC1. Importantly, an enhanced collagen organization was observed in FastSkin^® in contrast to NC treatments. In summary, two clinically approved skin wound treatments, namely micrografting and blood clot graft, were successfully merged with sound-induced patterning of micrografts to produce an autologous, simple, and biologically active wound treatment concept. Full article

Background: Tissue healing consists of four main phases: coagulation, inflammation, proliferation, and remodeling. In diabetic patients, this process is stagnant in the inflammatory stage, leading to chronic wounds. The aim of this study is to evaluate in an animal model the biological evidence related to the use of the Rigenera^® technology (Turin Italy), an innovative mechanical procedure to isolate autologous micrografts (AMG). Methods: Fifty male Wistar rats were divided into four groups: control (C), control treated with micrografts (CM), diabetic (DB), and diabetic treated with micrografts (DBM). The experimental setup involved: the quantification of the total collagen and elastic fibers; histopathological analysis; immunohistochemical analysis for collagen type I (COL1), collagen type III (COL3), vascular endothelial growth factor (VEGF-A), and interleukin 4 (IL4) and 10 (IL10); evaluation of the oxidative stress; measurement of gluthatione (GSH); and, finally, an enzyme-linked immunosorbent assay (ELISA) on tumor necrosis factor-α (TNF-α). Results: The AMG technology induces a faster healing process: VEGF-A, IL4, IL10, and GSH increased, while TNF-α and oxidative stress decreased. Conclusions: Animals treated with micrografts showed more favorable results for healing compared to those that did not receive treatment, demonstrating a positive participation of the micrografts in the treatment of difficult-to-heal wounds. Full article

The aim of this clinical study was to demonstrate that through a micrograft of viable adipose tissue cells microfiltered at 50 microns to exclude fibrous shoots and cell debris in a suspension of cross-linked hyaluronic acid, we were able to improve visible imperfections of the dermis and to improve clinically observable wrinkles, with a beneficial effect also in the extracellular matrix (ECM). Background and Objectives: With the passage of time, the aging process begins, resulting in a progressive impairment of tissue homeostasis. The main reason for the formation of wrinkles is the involution of the papillary dermis, as well as the loss of stem cell niches with compromise of the extra-cytoplasmic matrix (ECM), and the loss of hyaluronic acid, which helps to maintain the shape and resistance and that is contained in the connective tissue. Materials and Methods: This study involved 14 female patients who underwent dermal wrinkle correction and bio-regeneration over the entire facial area through a suspension containing 1.0 mL of viable micrografts from adipose tissue in a 1.0 mL cross-linked hyaluronic acid. To verify the improvement of the anatomical area concerned over time, the various degrees of correction obtained for wrinkles, and in general for texture, were objectively evaluated by using a Numeric Rating scale (NRS) 10–0, a modified Vancouver scale and a Berardesca scale. Results: The Berardesca, NRS and Modified Vancouver scales showed that with this technique it was possible to obtain excellent results both when the suspension was injected into wrinkles with the linear retrograde technique, and when it was injected with the micropomphs technique to correct furrows, with the intent to revitalize the tissue through progenitors with adult stemness markers. Conclusions: The combination of microfragmented and microfiltered adipose tissue and cross-linked hyaluronic acid at 50 microns is safe new method to treat soft tissue defects such as deep wrinkles. Full article

The purpose of this study was to estimate the safety, feasibility, and efficacy of the intra-articular treatment of autologous microfragmented adipose tissue in dogs with spontaneous osteoarthritis (OA) in comparison with hyaluronic acid (HA), the standard intra-articular treatment. Specifically, it clinically evaluated pain and lameness, the radiographic progression of osteoarthritis, and synovial fluid inflammation. This was a prospective, single-center, parallel-group, randomized, controlled, in vivo clinical study. Participants (n = 40) received either a single intra-articular injection of microfragmented adipose tissue or a single intra-articular injection of HA (1:1). Clinical outcomes were determined using a specialistic clinician assessment obtained by the completion of a specific clinical form based on the Vesseur modified lameness classification system, a pain evaluation using the Visual Analogue Scale (VAS), the measurement of the range of motion (ROM) of the affected joint, limb circumference, and the owners’ score evaluation using the Canine Brief Pain Inventory (CBPI) for up to 6 months after the time of injection. Patients underwent a radiographic examination to establish the degree of OA in the affected joint, and synovial fluid samples were collected to assess the biochemical environment of the joint and evaluate and quantify the cellular population and the presence of three specific inflammation biomarkers for up to 60 days. The results of this study suggest that microfragmented autologous adipose tissue is safe and can effectively relieve pain and improve function in dogs with spontaneous articular OA. This one-step procedure is simple, timesaving, cost-effective, minimally invasive, and eliminates the need for complex and time-intensive cell culture processing. Furthermore, the clinical evidence and cytological results suggest better long-term pain control, resulting in an improvement in joint function, compared to HA treatment. The canine spontaneous OA model could play a key role in developing successful treatments for human medicine. Full article

Background and Objectives: Wound healing (WH) is a complex natural process: the achieving of a proper WH with standard therapies sometimes is not fulfilled and it is often observed in aged and diabetic patients, leading to intractable ulcers. In recent years, autologous micrograft (AMG) therapies have become a new, effective, and affordable wound care strategy among both researchers and clinicians. In this study, a 72-year-old female patient underwent a combination of treatments using micrograft and negative pressure wound therapy (NPWT) on a postoperative skin ulcer after a benign tumor resection on the back with the aim to present an innovative method to treat skin ulceration using AMG combined with an artificial dermal scaffold and NPWT. Materials and Methods: A section of the artificial dermal scaffold, infused with micrografts, was sampled prior to transplant, and sections were collected postoperatively on days 3 and 7. Hematoxylin-eosin (HE) and immunohistochemical stains were employed for the evaluation of Cytokeratin AE1/AE3, desmin, and Factor VIII. Additionally, on postoperative day 3, NPWT dressing was evaluated using HE stains, as well. The resulting HE and immunostaining analysis revealed red blood cells and tissue fragments within the collagen layers of the artificial dermis prior to transplant. On postoperative day 3, collagen layers of the artificial dermis revealed red blood cells and neutrophils based on HE stains, and scattering of cytokeratin AE1/AE3-positive cells were detected by immunostaining. The HE stains on postoperative day 7 showed more red blood cells and neutrophils within the collagen layers of the artificial dermis than on day 3, an increase in cytokeratin AE1/AE3-positive cells, and tissue stained positively with desmin and Factor VIII. Results: Results suggest that the effects of both micrografts and migratory cells have likely accelerated the wound healing process. Furthermore, the NPWT dressing on day 3 showed almost no cells within the dressing. This indicated that restarting NPWT therapy immediately after micrograft transplant did not draw out cells within the scaffold. Conclusions: Micrograft treatment and NPWT may serve to be a useful combination therapy for complex processes of wound healing. Full article