121. A Phase II Open-Label, Randomized Clinical Trial of Atezolizumab with or without Human Recombinant IL-7 (CYT107) in Advanced Urothelial Cancer.
作者: Randy F Sweis.;Gurkamal S Chatta.;Rohit K Jain.;Helen Moon.;Scott Edward Delacroix.;Alana Fang.;Leonard D'Amico.;Angela Shaulov Kask.;Martin A Cheever.;Steven Fling.;Elad Sharon.;Andreanne Lacroix.;Judith C Kaiser.;Russell K Pachynski.;Evan Y Yu.
来源: Clin Cancer Res. 2025年31卷2期299-307页
Advanced urothelial cancer generally has high mortality despite modern anti-PD-1/L1 antibody-based combinations. Augmenting checkpoint inhibitor-mediated immune responses with lymphocyte growth factors may improve outcomes. We conducted a randomized phase II study (Cancer Immunotherapy Trials Network-14) in 47 patients to explore whether human recombinant IL-7 (CYT107) could be safely combined with PD-L1 inhibition to enhance responses.
122. Long term outcomes of intracarotid arterial transfusion of circulatory-derived autologous CD34 + cells for acute ischemic stroke patients-A randomized, open-label, controlled phase II clinical trial.
作者: Hung-Sheng Lin.;Pei-Hsun Sung.;Shu-Hua Huang.;Wei-Che Lin.;John Y Chiang.;Ming-Chun Ma.;Yi-Ling Chen.;Kuan-Hung Chen.;Fan-Yen Lee.;Sheung-Fat Ko.;Hon-Kan Yip.
来源: Stem Cell Res Ther. 2024年15卷1期443页
This phase II randomized controlled trial tested whether the intracarotid arterial administration (ICAA) of autologous CD34 + cells to patients within 14 ± 7 days after acute ischemic stroke (IS) could be safe and further improve short- and long-term outcomes.
123. Autologous transplantation of P63+ lung progenitor cells in patients with bronchiectasis: A randomized, single-blind, controlled trial.
作者: Jiayang Yan.;Weipan Zhang.;Yun Feng.;Xuefei Liu.;Lingyun Niu.;Yi Guo.;Ling Zhou.;Mengmeng Shi.;Caixia Di.;Qiurui Zhang.;Xiaofei Wang.;Jianping Zhou.;Ranran Dai.;Lei Ni.;Zhiyao Bao.;Tianli Yan.;Yun Hu.;Ping Wang.;Ting Zhang.;Min Zhou.;Wei Zuo.;Jieming Qu.
来源: Cell Rep Med. 2024年5卷11期101819页
Non-cystic fibrosis bronchiectasis is a progressive respiratory disease with limited treatment options, prompting the exploration of regenerative therapies. This study investigates the safety and efficacy of autologous P63+ progenitor cell transplantation in a randomized, single-blind, controlled, phase 1/2 trial. Thirty-seven patients receive bronchoscopic airway clearance (B-ACT) (n = 19) or B-ACT plus P63+ progenitor cells (n = 18). Results show that compared to the control group, the change in DLCO levels from baseline to 24 weeks post therapy is significantly higher in the cell treatment group (p value = 0.039). Furthermore, the patients in the cell treatment group demonstrate significantly reduced lung damaged area, improved SGRQ score, and ameliorated BSI and FACED scores within 4-12 weeks post therapy. Transcriptomic analysis reveals that progenitor cells with higher expression of P63 gene have better therapeutic efficacy. These findings suggest that P63+ progenitor cells may offer a promising therapeutic approach for bronchiectasis. This study was registered at ClinicalTrials.gov(NCT03655808).
124. Clinical outcomes of autologous adipose-derived mesenchymal stem cell combined with high tibial osteotomy for knee osteoarthritis are correlated with stem cell stemness and senescence.
作者: Houyi Sun.;Haoxin Zhai.;Kaifei Han.;Heran Ma.;Yi Tan.;Shihao Li.;Zhicheng Liu.;Lei Cheng.;Qunshan Lu.;Libo Zhou.;Peilai Liu.
来源: J Transl Med. 2024年22卷1期1039页
Mesenchymal stem cells (MSCs) have been proposed to treat osteoarthritis (OA) for many years. However, clinical outcomes have been inconsistent due to biological variation between patients, differences in tissue source and preparation of the MSCs, and type of donor (e.g. allogenic versus autologous). Here, we test the hypothesis that inconsistent clinical outcomes are related to variations in the stemness and senescence of the injected autologous adipose-derived (AD) MSCs.
125. Comparing stem cell mobilization with chemotherapy and cytokine (G-CSF) versus cytokine alone in myeloma patients (MOCCCA): a randomized phase II, open-label, non-inferiority trial.
作者: Barbara Jeker.;Laura Thalmann.;Ulrike Bacher.;Henning Nilius.;Gaëlle Rhyner.;Martin Sökler.;Susanne Soltermann.;Annette Winkler.;Corinne Vorburger.;Michael Daskalakis.;Michèle Hoffmann.;Thomas Pabst.
来源: Bone Marrow Transplant. 2025年60卷3期270-276页
In fit patients with newly diagnosed myeloma, high-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) is considered standard of care. For mobilization of CD34+ cells for ASCT, combined cytotoxic chemotherapy and G-CSF is commonly used. However, the importance of cytostatic chemotherapy for reliable mobilization remains unclear. This prospective randomized phase II non-inferiority trial compared G-GSF only (G) compared to standard chemotherapy/G-CSF (CG) for CD34+ mobilization. The primary endpoint was a less than 15% difference in successful stem cell collection ( ≥ 5.0 × 106 CD34+ cells/kg b.w. in a single day collection procedure without additional stimulation with plerixafor) with the G regimen. 136 patients were 1:1 randomized. With an 18% difference in favor of the CG therapy, the non-inferiority margin was not maintained (95% CI 1%, 34%, p = 0.04). The median total CD34+ yield was 9.99 × 106/kg b.w. in CG patients and 7.42 × 106/kg b.w. in patients with G-CSF alone (p < 0.001). Ultimately, 130 (96%) patients proceeded to HDCT with ASCT. There were no differences in adverse events, hematologic engraftment, quality of life, or pain perception between the groups. Our data indicate that G-CSF only is inferior to chemotherapy with G-CSF for peripheral CD34+ stem cell mobilization. Trial registration SNCTP #: SNCTP000002952; Trials.gov #: NCT03442673.
126. Clinical outcome is unlinked to injection of adipose-derived regenerative cells in the axilla of breast cancer-related lymphedema patients.
作者: Ditte Caroline Andersen.;Frederik Adam Bjerre.;Mads Gustaf Jørgensen.;Jens Ahm Sørensen.;Charlotte Harken Jensen.
来源: Stem Cell Res Ther. 2024年15卷1期426页
Injection of autologous adipose-derived regenerative cells (ADRCs) combined with lipotransfer has been suggested to alleviate symptoms in diseases including breast cancer-related lymphedema (BCRL). We recently performed a randomized controlled trial injecting lipoaspirate with ADRCs into the axilla of BCRL patients, and here we aimed in the intervention group to define in an unbiased fashion whether ADRC injection was linked to the clinical outcome.
127. Improvement of Neurogenic Bladder Dysfunction Following Combined Cell Therapy with Mesenchymal Stem Cell and Schwann Cell in Spinal Cord Injury: A Randomized, Open-Label, Phase II Clinical Trial.
作者: Mohammadhosein Akhlaghpasand.;Roozbeh Tavanaei.;Farzad Allameh.;Maede Hosseinpoor.;Hossein Toreyhi.;Maryam Golmohammadi.;Atieh Hajarizadeh.;Alireza Alikhani.;Maryam Hafizi.;Maryam Oraee-Yazdani.;Alireza Zali.;Saeed Oraee-Yazdani.
来源: World Neurosurg. 2025年194卷123402页
To investigate the efficacy of intrathecal combined administration of autologous bone marrow-derived mesenchymal stem cells (BMSCs) and Schwann cells (SCs) in urinary function improvement in complete spinal cord injury (SCI) patients for the first time.
128. Efficacy of a single dose of cryopreserved human umbilical cord mesenchymal stromal cells for the treatment of knee osteoarthritis:a randomized, controlled, double-blind pilot study.
作者: Omar Amado Pico.;Francisco Espinoza.;María Ignacia Cádiz.;Claudia L Sossa.;Silvia M Becerra-Bayona.;María C Canencio Salgado.;Javier Eduardo Rengifo Rodríguez.;Oscar Fabian Valdivieso Cárdenas.;Johanna Marcela Quintero Cure.;Maroun Khoury.;Martha L Arango-Rodríguez.
来源: Cytotherapy. 2025年27卷2期188-200页
Knee osteoarthritis (OA) is the most prevalent degenerative musculoskeletal disorder, which is particularly common in older population. While conventional treatments have limited effectiveness, the development of more effective therapeutic strategies is necessary to address this primary source of pain and disability. Umbilical cord mesenchymal stromal cells (UC-MSCs) offer a promising therapeutic approach for treating knee OA.
129. Effects of non-digestible carbohydrates on gut microbiota and microbial metabolites: a randomised, controlled dietary intervention in healthy individuals.
作者: Fiona C Malcomson.;Panayiotis Louca.;Andrew Nelson.;Naomi D Willis.;Iain McCallum.;Long Xie.;Arthur C Ouwehand.;Julian D Stowell.;Tom Preston.;Douglas J Morrison.;Seamus B Kelly.;D Michael Bradburn.;Nigel J Belshaw.;Ian T Johnson.;Bernard M Corfe.;Christopher J Stewart.;John C Mathers.
来源: Br J Nutr. 2024年132卷11期1433-1445页
The gut microbiome is impacted by certain types of dietary fibre. However, the type, duration and dose needed to elicit gut microbial changes and whether these changes also influence microbial metabolites remain unclear. This study investigated the effects of supplementing healthy participants with two types of non-digestible carbohydrates (resistant starch (RS) and polydextrose (PD)) on the stool microbiota and microbial metabolite concentrations in plasma, stool and urine, as secondary outcomes in the Dietary Intervention Stem Cells and Colorectal Cancer (DISC) Study. The DISC study was a double-blind, randomised controlled trial that supplemented healthy participants with RS and/or PD or placebo for 50 d in a 2 × 2 factorial design. DNA was extracted from stool samples collected pre- and post-intervention, and V4 16S rRNA gene sequencing was used to profile the gut microbiota. Metabolite concentrations were measured in stool, plasma and urine by high-performance liquid chromatography. A total of fifty-eight participants with paired samples available were included. After 50 d, no effects of RS or PD were detected on composition of the gut microbiota diversity (alpha- and beta-diversity), on genus relative abundance or on metabolite concentrations. However, Drichlet's multinomial mixture clustering-based approach suggests that some participants changed microbial enterotype post-intervention. The gut microbiota and fecal, plasma and urinary microbial metabolites were stable in response to a 50-d fibre intervention in middle-aged adults. Larger and longer studies, including those which explore the effects of specific fibre sub-types, may be required to determine the relationships between fibre intake, the gut microbiome and host health.
130. Comparison of microneedling and CO2 laser with adipose-derived stem cells for facial rejuvenation: a randomized split-face study.
作者: Alejandra delaO-Escamilla.;Jair A Valdez-Zertuche.;Jorge Lara-Arias.;Andrés Noyola-Pérez.;Alejandra Villarreal-Martínez.;Sonia Chávez-Álvarez.;Adrián Cuéllar-Barboza.;Rodolfo Franco-Márquez.;Jorge Ocampo-Candiani.;Osvaldo T Vázquez-Martínez.
来源: Int J Dermatol. 2025年64卷4期702-711页
Facial aging, characterized by structural decline and loss of collagen and elastin, has led to increased demand for rejuvenation treatments. Adipose-derived stem cells (ADSCs) have emerged as a promising option, but comparative studies on their application methods are limited.
131. The Effect of Multi-Ingredient Protein versus Collagen Supplementation on Satellite Cell Properties in Males and Females.
作者: Mai Wageh.;Stephen A Fortino.;Riley Pontello.;Ahmed Maklad.;Chris McGlory.;Dinesh Kumbhare.;Stuart M Phillips.;Gianni Parise.
来源: Med Sci Sports Exerc. 2024年56卷11期2125-2134页
Skeletal muscle satellite cells (SC) contribute to the adaptive process of resistance exercise training (RET) and may be influenced by nutritional supplementation. However, little research exists on the impact of multi-ingredient supplementation on the SC response to RET.
132. Safety and efficacy of placental mesenchymal stromal cells-derived extracellular vesicles in knee osteoarthritis: a randomized, triple-blind, placebo-controlled clinical trial.
作者: Najmeh Sadat Bolandnazar.;Seyed Ahmad Raeissadat.;Hamidreza Haghighatkhah.;Seyed Mansoor Rayegani.;Rasa Salmani Oshnari.;Saeed Heidari Keshel.;Mohammad Zahraei.;Kianmehr Aalipour.;Marzieh Babaee.;Amir Zamani.;Zahra Besharati Rad.;Masoud Soleimani.;Farshid Sefat.
来源: BMC Musculoskelet Disord. 2024年25卷1期856页
Knee osteoarthritis causes pain and disability in many people worldwide, for which no definitive treatment has yet been proposed. In this study, we investigated the safety and efficacy of placental mesenchymal stromal cells-derived extracellular vesicles in patients with knee osteoarthritis.
133. Gut Microbiome and Metabolome Alterations in Overweight or Obese Adult Population after Weight-Loss Bifidobacterium breve BBr60 Intervention: A Randomized Controlled Trial.
作者: Zhouya Bai.;Ying Wu.;Dejiao Gao.;Yao Dong.;Yujia Pan.;Shaobin Gu.
来源: Int J Mol Sci. 2024年25卷20期
Probiotics, known for regulating gut microbiota, may aid those with overweight or obesity, but their mechanisms require more research. This study involved 75 overweight or obese young adults, randomly assigned to either a Bifidobacterium breve BBr60 (BBr60) group or a placebo group. Both groups received diet guidance and took either BBr60 (1 × 1010 CFU/day) or a placebo for 12 weeks. Researchers analyzed body composition, serum glucose, lipids, liver and kidney function, comprehensive metabolome, and intestinal homeostasis before and after the intervention. After 12 weeks, BBr60 significantly reduced weight and BMI compared to pretreatment levels and outperformed the placebo. The BBr60 group also showed improved blood biochemistry, with notably lower fasting blood glucose (FBG) levels than the placebo group (p < 0.05). Additionally, BBr60 influenced vital serum and fecal metabolites related to three amino acid metabolic pathways and regulated the bacteria Dialister, Klebsiella, and Bacteroides, which correlated strongly with serum metabolites. These findings indicate that BBr60 can safely and effectively regulate BMI, body weight, serum glucose, lipids, and liver function markers, which may involve BBr60's impact on key gut bacteria, which influence metabolites related to the valine, leucine, and isoleucine biosynthesis; glycine, serine, and threonine metabolism; and alanine, aspartate, and glutamate metabolism.
134. Simple limbal epithelial transplantation versus cultivated limbal epithelial transplantation in ocular burns.
作者: Namrata Sharma.;Renu Venugopal.;Sujata Mohanty.;K Priyadarshini.;Ritu Nagpal.;Deepali Singhal.;Aafreen Bari.;Tanuj Dada.;Prafulla Kumar Maharana.;Tushar Agarwal.;Ashish Dutt Upadhyay.
来源: Ocul Surf. 2024年34卷504-509页
To compare the outcomes of simple limbal epithelial transplantation (SLET) with cultivated limbal epithelial transplantation (CLET) for the management of total limbal stem cell deficiency (LSCD) in eyes with unilateral ocular burns.
135. Does Injectable Platelet-Rich Fibrin Combined With Autogenous Demineralized Dentine Enhance Alveolar Ridge Preservation? A Randomized Controlled Trial.
作者: Odai Amer.;Nesma Shemais.;Karim Fawzy El-Sayed.;Heba Ahmed Saleh.;Mona Darhous.
来源: Clin Oral Implants Res. 2025年36卷2期166-177页
The present trial evaluated the first-time application of autogenous demineralized dentin graft with injectable platelet-rich fibrin (ADDG + i-PRF) versus autogenous demineralized dentin graft (ADDG), in alveolar ridge preservation (ARP) in the maxillary aesthetic zone.
136. Comparative evaluation of autologous tissue-engineered ocular and oral mucosal tissue grafts- a prospective randomized controlled trial.
作者: Radhika Tandon.;Pranav Kumar Pandey.;Tanveer Alam Khan.;Amit Kumar Das.;Mani Kalaivani.;Misba Majood.;Seema Kashyap.;Seema Sen.;Neiwete Lomi.;Noopur Gupta.;M Vanathi.;Sujata Mohanty.
来源: BMC Biotechnol. 2024年24卷1期82页
Bilateral ocular surface disease resulting from Stevens Johnson Syndrome (SJS) and chemical injuries are visually debilitating and difficult to treat. Ocular surface reconstruction by various means has been reported with variable results. This study addresses an unmet need for a prospective clinical trial comparing the outcomes of transplanting autologous oral and conjunctival epithelial cell constructs on human amniotic membrane by ex vivo tissue engineering.
137. Allogenic bone marrow-derived mesenchymal stromal cell-based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study).
作者: Yves-Marie Pers.;Robert Soler-Rich.;Gianluca Vadalà.;Rosanna Ferreira.;Claire Duflos.;Marie-Christine Picot.;Fanchon Herman.;Sylvie Broussous.;Ana Sánchez.;David Noriega.;Francisco Ardura.;Mercedes Alberca Zaballos.;Verónica García.;Virginia Gordillo Cano.;Margarita González-Vallinas.;Vicenzo Denaro.;Fabrizio Russo.;Jérôme Guicheux.;Joan Vilanova.;Lluís Orozco.;Hans-Jörg Meisel.;Matias Alfonso.;Francois Rannou.;Yves Maugars.;Francis Berenbaum.;Frank P Barry.;Karin Tarte.;Pascale Louis-Plence.;Guilherme Ferreira-Dos-Santos.;Javier García-Sancho.;Christian Jorgensen.; .
来源: Ann Rheum Dis. 2024年83卷11期1572-1583页
To assess the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP).
138. Functional outcome and histologic analysis of late onset total type brachial plexus injury treated with intercostal nerve transfer to median nerve with local umbilical cord-derived mesenchymal stem cells or secretome injection: a double-blinded, randomized control study.
作者: Wahyu Widodo.;Ismail Hadisoebroto Dilogo.;Achmad Fauzi Kamal.;Radiana Dhewayani Antarianto.;Puspita Eka Wuyung.;Nurjati Chairani Siregar.;Fitri Octaviana.;Aria Kekalih.;Heri Suroto.;Wildan Latief.;Witantra Dhamar Hutami.
来源: Eur J Orthop Surg Traumatol. 2024年34卷8期4073-4082页
Intercostal nerve transfer is a surgical technique used to restore function in patients with total brachial plexus injury. Stem cell and secretome therapy has been explored as a potential treatment for brachial plexus injuries. This study aimed to compare the functional and histologic outcome of intercostal nerve transfer to median nerve with local stem cells or secretome injection in total type brachial plexus injuries.
139. Bone marrow mesenchymal stem cell and mononuclear cell combination therapy in patients with type 2 diabetes mellitus: a randomized controlled study with 8-year follow-up.
作者: Zhixian Wu.;Shulin Huang.;Shasha Li.;Jinquan Cai.;Lianghu Huang.;Weizhen Wu.;Jin Chen.;Jianming Tan.
来源: Stem Cell Res Ther. 2024年15卷1期339页
To investigate the long-term effects of combining bone marrow mesenchymal stem cells (MSCs) with mononuclear cells (MCs) in the treatment of type 2 diabetes mellitus (T2DM).
140. Summary of quality of life in the ASCENT phase 3 clinical trial for people with metastatic triple-negative breast cancer.
作者: Sibylle Loibl.;Delphine Loirat.;Sara M Tolaney.;Kevin Punie.;Véronique Dieras.;Lisa A Carey.;Luca Gianni.;Anuj Shah.;See Phan.;Ling Shi.;Patricia A Spears.;Martine J Piccart.
来源: Future Oncol. 2024年20卷34期2609-2616页
A medicine called sacituzumab govitecan (brand name TRODELVY®) has been proven to be an effective treatment for metastatic triple-negative breast cancer (mTNBC for short). Metastatic breast cancer is cancer that has spread to other parts of the body. In mTNBC, the breast cancer cells do not have 3 common proteins on the cell surface, called receptors. mTNBC is more difficult to treat and more likely to come back than other types of breast cancer. The ASCENT study showed that participants with mTNBC treated with sacituzumab govitecan had a higher likelihood of living longer and delayed progression (worsening) of their cancer than those treated with standard chemotherapy. Here, we summarize the quality of life of participants with mTNBC in the ASCENT study. We compared quality of life between 236 participants treated with sacituzumab govitecan and 183 participants treated with standard chemotherapy. All participants previously received 2 or more chemotherapies that no longer controlled their cancer.
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