Tag: safety

Response to “Knowledge Gaps in Long-Term Phentermine Use”

This 2019 letter addresses concerns raised about the long-term use of phentermine for weight management. The authors acknowledge existing gaps in knowledge regarding the safety and efficacy of extended phentermine use but highlight emerging evidence suggesting its potential benefits. They reference observational studies indicating that prolonged phentermine therapy may lead

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Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial)

This Phase 1/2 double-blind, placebo-controlled trial assessed the safety and efficacy of intravenous allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in 30 patients with chronic stable heart failure and reduced ejection fraction (HFrEF) under optimal medical therapy. Patients were randomized to receive a single infusion of UC-MSCs (1×10^6 cells/kg) or

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A Placebo-Controlled, Randomized Trial of Mesenchymal Stem Cells in COPD

This Phase II, multicenter, randomized, double-blind, placebo-controlled trial evaluated the safety and preliminary efficacy of systemic administration of allogeneic mesenchymal stem cells (MSCs) in 62 patients with moderate to severe COPD. Participants received four monthly intravenous infusions of 100 million MSCs (Prochymal) or placebo and were followed for two years.

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Clinical Trial of Human Umbilical Cord Blood-Derived Stem Cells for the Treatment of Moderate-to-Severe Atopic Dermatitis: Phase I/IIa Studies

This Phase I/IIa clinical trial evaluated the safety and efficacy of subcutaneous injections of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) in 34 adult patients with moderate-to-severe atopic dermatitis (AD). Participants were randomized to receive either a low dose (2.5 × 10⁷ cells) or a high dose (5.0 ×

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Serious Adverse Events of Cell Therapy for Respiratory Diseases: A Systematic Review and Meta-Analysis

This systematic review and meta-analysis assessed the safety profile of cell-based therapies in respiratory diseases by analyzing 23 clinical studies involving 204 patients with conditions such as ARDS, COPD, IPF, PAH, and others. The findings indicated that both systemic infusions and bronchial instillations of mesenchymal stem/stromal or progenitor cells were

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Concise Review: Stem Cell Interventions for People With Cerebral Palsy: Systematic Review With Meta-Analysis

This systematic review and meta-analysis evaluated the efficacy and safety of stem cell therapies in individuals with cerebral palsy (CP). Analyzing five clinical trials encompassing 328 participants, the study examined various stem cell types, including olfactory ensheathing cells, neural stem cells, neural progenitors, and allogeneic umbilical cord blood cells. The

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Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis

This systematic review and meta-analysis evaluated the safety and efficacy of mesenchymal stem cell (MSC) therapy in adults with acute myocardial infarction (AMI) and ischemic heart failure (IHF). Analyzing 23 clinical trials (11 on AMI and 12 on IHF), the study found that MSC therapy was not associated with acute

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Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium in Patients with Age-Related Macular Degeneration and Stargardt’s Macular Dystrophy: Follow-Up of Two Open-Label Phase 1/2 Studies

This study reports on two open-label Phase 1/2 trials assessing the safety and tolerability of subretinal transplantation of human embryonic stem cell-derived retinal pigment epithelium (hESC-RPE) in nine patients with atrophic age-related macular degeneration (AMD) and nine with Stargardt’s macular dystrophy. Patients received varying doses (50,000 to 150,000 cells) and

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Intra-articular Injections of Expanded Mesenchymal Stem Cells with and without Addition of Platelet-Rich Plasma Are Safe and Effective for Knee Osteoarthritis

This randomized controlled trial evaluated the safety and efficacy of intra-articular injections of autologous expanded mesenchymal stem cells (MSCs) alone or combined with platelet-rich plasma (PRP) in 18 patients with symptomatic knee osteoarthritis (OA). Participants were randomized to receive either MSCs alone or MSCs plus PRP. Both groups demonstrated significant

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Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial

This Phase I/II randomized controlled trial assessed the safety and efficacy of intra-articular injections of umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with symptomatic knee osteoarthritis (OA). Participants were randomized into three groups: hyaluronic acid (HA) injections at baseline and 6 months (n=8), a single UC-MSC dose at baseline

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