Regenerative medicine最新文献

Smart hydrogels have become precision platforms that interact with complex biological cues. We formalize a 2025 definition, materials that sense a clinically relevant cue and reproducibly execute a specified, reversible function under physiologic conditions, and introduce a unified, feature-based, three-tier framework: Responsive (open-loop cue and response), Adaptive (multi-cue or stateful), and Intelligent (closed-loop sense, decide, and act). This review captures momentum from 2020 to 2025, a period marked by clinical and innovative breakthroughs, FDA-cleared formulations, and integration of advanced technologies, including AI-assisted design, fourth-dimensional (4D) bioprinting, and biohybrid interfaces. We spotlight cutting-edge developments in programmable degradation, self-healing, and multi-stimuli responsiveness, alongside emerging hydrogel fabrication strategies such as nanoparticle (NP)-laden bioinks and in situ light-activated crosslinking. Although barriers to regulation and translation remain, cross-disciplinary efforts with a sustainability- and ethics-first mind-set are redefining these materials' capabilities. Smart hydrogels are no longer just innovative, researchers in tissue engineering and regenerative medicine are actively redefining both their clinical potential and what it means for a material to be "smart."

Three-dimensional (3D) bioprinting has emerged as a promising biofabrication strategy for bone regeneration, offering unprecedented control over the spatial distribution of cells, biomaterials, and bioactive cues. By enabling the production of anatomically customized grafts with microarchitectural complexity and biological functionality, bioprinting holds potential to overcome limitations associated with autografts, allografts, and synthetic bone substitutes. This review provides a comprehensive synthesis of recent advances in bioprinting technologies, bioink design, and recent in vitro and in vivo studies targeting bone tissue engineering. Despite encouraging preclinical outcomes, the field faces significant challenges, including limited mechanical performance, control over cellular microenvironments, lack of standardization, and trade-offs between printing resolution and scalability. Notably, no clinical trials have yet investigated bioprinted bone constructs, reflecting the translational hurdles that persist. We critically discuss these gaps and propose strategic directions. Collectively, this review underscores the feasibility of 3D bioprinting for bone regeneration while highlighting the key scientific and technical milestones needed to transition from bench to bedside.

Cell-based therapies have emerged as a promising frontier in regenerative medicine, offering potential treatments for various degenerative, autoimmune, and genetic disorders. However, their clinical translation is accompanied by complex ethical and regulatory challenges that must be addressed to ensure patient safety, equitable access, and scientific integrity. This review explores the intricate landscape of global regulatory frameworks governing cell-based therapies, highlighting key obstacles such as inconsistent international guidelines, prolonged approval timelines, and ethical considerations. The lack of regulatory harmonization often impedes innovation and delays the availability of advanced treatments to patients in need. In addition, stringent requirements can pose barriers for emerging biotech start-ups, limiting competition and technological advancements. Despite these challenges, regulatory frameworks also present opportunities to foster innovation, enhance patient safety, and streamline drug approval process. Collaborative efforts between policymakers, regulatory bodies, industry leaders, and research institutions are crucial to developing standardized yet adaptable guidelines that accommodate scientific progress while maintaining stringent safety protocols. By fostering a regulatory ecosystem that encourages innovation without compromising safety, stakeholders can unlock the potential of cell-based therapies, paving the way for their widespread adoption and integration into clinical practice.

Aim: This review evaluates CRISPR-based strategies for myelin regeneration in peripheral demyelinating disorders, with a focus on Guillain - Barré syndrome (GBS) and Charcot - Marie - Tooth disease type 1A (CMT1A). It aims to identify current therapeutic approaches, delivery systems, and gaps in the literature.

Materials & methods: A systematic literature search was conducted across PubMed, Scopus, Web of Science, and Google Scholar for studies published from 2010 onward, following PRISMA guidelines. Study quality was assessed using OHAT and SYRCLE tools, and 14 articles met the inclusion criteria.

Results: In GBS, CRISPR interventions primarily targeted antiviral immune regulation (AXL, IFI6, IFNL2), inhibition of viral entry mechanisms (Integrin αvβ5, SPCS1), and Schwann cell repair. In CMT1A, therapeutic approaches focused on correcting PMP22 overexpression. Lentiviral transduction was the most frequently used delivery method, with no major adverse effects reported. However, most studies were in vitro, and only two were in vivo, highlighting the need for further validation in animal models.

Conclusions: CRISPR technology shows considerable potential for addressing peripheral nerve demyelination through precise genetic modifications that may enhance Schwann cell function and support myelin repair. Nevertheless, the field remains at an early discovery stage, with no near-term clinical applicability demonstrated.

Background: Stroke-related long-term disability is primarily due to impaired motor function. Rehabilitation efforts have traditionally focused on central strategies while ignoring the affected muscles. Regenerative medicine approaches have emerged as a promising option for treating various conditions, including muscular disorders. The present study aims to compare the effects of intramuscular injections of mesenchymal stromal cells (MSCs) and Platelet-rich plasma (PRP) on motor recovery in poststroke survivors.

Methods: A single-blind, randomized, controlled trial will be followed. Fifteen stroke patients who meet the eligibility criteria will be randomly assigned to the cell therapy, PRP, or waiting-list control groups. Patients in each group will receive a single injection of MSCs or PRP into their affected biceps brachii muscle. Patients in the waiting list control group will receive no intervention. The outcome measures include the Modified Modified Ashworth Scale (MMAS), Brunnstrom recovery stages for the upper limb, elbow range of motion, and sonographic evaluations. All outcome measures will be assessed at baseline, 1, 2, and 3 months after injection.

Conclusions: The findings of this study will provide initial supportive evidence regarding the efficacy of MSCs and PRP therapy in improving biceps brachii muscle spasticity and function in patients with chronic stroke.

Trial registration: IRCT20230208057351N1.

Background and aims: Allogeneic mesenchymal stromal cell (ASC) therapy is a potential treatment option in patients with ischemic heart failure (HF). We aimed to investigate the effect of allogeneic Cardiology Stem Cell Center Adipose tissue derived mesenchymal Stromal Cell product (CSCC_ASC) by joining data from the international SCIENCE and the Danish ASC trial.

Methods: Data from two double-blinded placebo-controlled phase II studies including patients with same inclusion and exclusion criteria and identical endpoints were combined. Patients had left ventricular ejection fraction (LVEF) < 45% and New York Heart Association (NYHA) II-III without further treatment options.

Results: Two hundred and fourteen patients were randomly assigned to receive CSCC_ASCs or placebo injections. There was no difference in baseline characteristics between groups.No significant differences from baseline to 6-month follow-up were detected between the intervention and placebo-group in left ventricular end-systolic volume, end-diastolic volume or LVEF (p = 0.973, p = 0.601, p = 0.152). The 6-min walking test, NYHA-classification and quality of life score were unchanged in both groups. The difference between groups in N-terminal pro B-type natriuretic peptide and C-reactive protein at 6 months was statistically significant (p = 0.045, p = 0.021).

Conclusions: Post-hoc analysis demonstrated that a single intramyocardial CSCC_ASC injection in patients with chronic ischemic no-option HF did not improve cardiac function.

Latest developments in the field of Advanced Therapy Medicinal Products and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in July 2025.

Latest developments in the field of Advanced Therapy Medicinal Products and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in August 2025.

Mesenchymal stem cells (MSCs) contribute significantly to wound healing due to their ability to self-renew, modulate immune responses, and differentiate into various cell types. However, challenges such as unpredictable growth, limited vascular transport efficiency, stringent storage and maintenance requirements that limit the widespread clinical use of MSC-based therapy, highlighting the need for developing effective cell-free alternatives. The regenerative effects of MSCs are mediated through paracrine signaling, primarily via their secretome, which includes extracellular vesicles and soluble factors, especially exosomes. Compared to MSC therapy, exosomes provide superior benefits in terms of storage, safety, and efficiency in targeting the wound sites due to their enhanced tissue penetration capabilities. However, a specific aspect that remains underexplored in exosome-based therapy for wound healing is the development of optimized delivery systems, to ensure controlled, sustained release and precise localization of the exosomes at the wound sites. This review uniquely focuses on this critical and emerging area, providing a detailed overview of the current advancements and limitations in exosomes-based wound healing therapies, with a focus on their delivery strategies. The insights presented in this review are expected to accelerate the development of innovative, effective treatments, revolutionizing wound care management and advancing regenerative medicine in clinical practice.

Mesenchymal stromal cell (MSC) therapy is an injectable, orthobiologic treatment for patients with knee osteoarthritis (OA). The purpose of this narrative review is to evaluate the literature on allogeneic MSCs used in knee OA patients and to report on clinical outcomes. A comprehensive literature search was performed using the following keywords: osteoarthritis, knee, stem cell transplantation, allogeneic or allogenic, human mesenchymal stem cells, and human mesenchymal stromal cells. There was no restriction on time, and subjective and objective clinical outcomes were reported. A total of 11 (n = 11) clinical trial studies were included. The most common allogeneic source was adipose tissue (AD-MSCs). Most studies included a control group and included participants with Kellgren-Lawrence grades of II-III or II-IV. The MSC dose used was highly variable. There were no significant adverse safety events. All studies reported an improvement in patient reported outcomes from baseline, with the most common observation being a durable reduction in pain for 6 to 24 months. There were positive effects of AD-MSCs on cartilage imaging in most studies, although outcomes were variable. Allogeneic MSC injections for knee OA resulted in improved OA related symptom scores, are safe, and provided patients with a reduction in pain at long-term follow-up.