Trial reportOncotarget2016
Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty.
Trial report in Oncotarget, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 31 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I/II, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Aging Frailty
Use of Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Cases Of Frailty and Aging Processes Using Autologous Stem-Stromal Cell Infusion in Patients With Aging Frailty And Wellness
Clinical Study of Mesenchymal Stem/Stromal Cell Therapy in Frailty: a Proposed Experimental Design for Therapeutic and Mechanism Investigation
Who cites it
31 citing papers in PubMed.
- Randomized phase 2b dose-escalation trial of stem cell therapy with laromestrocel for aging frailty.Cell stem cell · 2026Trial
- Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial.The journals of gerontology. Series A, Biological sciences and medical sciences · 2017Trial
- Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty.The journals of gerontology. Series A, Biological sciences and medical sciences · 2017Trial
- Recent progress in stem cell and immune cell-based interventions for aging and age-related disorders.Frontiers in aging · 2025Review
- [Immunomodulatory mechanism of umbilical cord mesenchymal stem cells modified by miR-125b-5p in systemic lupus erythematosus].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2024Article
- qMAP enabled microanatomical mapping of human skin aging.bioRxiv : the preprint server for biology · 2024Article
- Application of mesenchymal stem cells for anti-senescence and clinical challenges.Stem cell research & therapy · 2023Review
- Recent clinical trials with stem cells to slow or reverse normal aging processes.Frontiers in aging · 2023Review
- Review
- Clinical Study of Mesenchymal Stem/Stromal Cell Therapy for the Treatment of Frailty: A Proposed Experimental Design for Therapeutic and Mechanistic Investigation.The journals of gerontology. Series A, Biological sciences and medical sciences · 2022Article
- Physiological Systems in Promoting Frailty.Comprehensive Physiology · 2022Review
- Interventions for Frailty Among Older Adults With Cardiovascular Disease: JACC State-of-the-Art Review.Journal of the American College of Cardiology · 2022Review
- Mesenchymal stem cells: ideal seeds for treating diseases.Human cell · 2021Review
- Mesenchymal Stem Cell Transplantation for the Treatment of Age-Related Musculoskeletal Frailty.International journal of molecular sciences · 2021Review
- Article
- Application of mesenchymal stem cell therapy for aging frailty: from mechanisms to therapeutics.Theranostics · 2021Review
- Inhalational delivery of induced pluripotent stem cell secretome improves postpneumonectomy lung structure and function.Journal of applied physiology (Bethesda, Md. : 1985) · 2020Article
- Measuring biological aging in humans: A quest.Aging cell · 2020Review
- Mesenchymal Stem Cell Senescence and Rejuvenation: Current Status and Challenges.Frontiers in cell and developmental biology · 2020Review
- Potential Role of Cellular Senescence in Asthma.Frontiers in cell and developmental biology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
Frailty is a syndrome associated with reduced physiological reserves that increases an individual's vulnerability for developing increased morbidity and/or mortality. While most clinical trials have focused on exercise, nutrition, pharmacologic agents, or a multifactorial approach for the prevention and attenuation of frailty, none have studied the use of cell-based therapies. We hypothesize that the application of allogeneic human mesenchymal stem cells (allo-hMSCs) as a therapeutic agent for individuals with frailty is safe and efficacious. The CRATUS trial comprises an initial non-blinded phase I study, followed by a blinded, randomized phase I/II study (with an optional follow-up phase) that will address the safety and pre-specified beneficial effects in patients with the aging frailty syndrome. In the initial phase I protocol, allo-hMSCs will be administered in escalating doses via peripheral intravenous infusion (n=15) to patients allocated to three treatment groups: Group 1 (n=5, 20 million allo-hMSCs), Group 2 (n=5, 100 million allo-hMSCs), and Group 3 (n=5, 200 million allo-hMSCs). Subsequently, in the randomized phase, allo-hMSCs or matched placebo will be administered to patients (n=30) randomly allocated in a 1:1:1 ratio to one of two doses of MSCs versus placebo: Group A (n=10, 100 million allo-hMSCs), Group B (n=10, 200 million allo-hMSCs), and Group C (n=10, placebo). Primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCs administered in frail older individuals. This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.