A5024963146- Mesenchymal stem cell research
- Pancreatic function and diabetes
- Tissue Engineering and Regenerative Medicine
- Diabetes Management and Research
- Extracellular vesicles in disease
- Nerve injury and regeneration
- Neonatal Respiratory Health Research
- Diabetes and associated disorders
- Cannabis and Cannabinoid Research
- Nerve Injury and Rehabilitation
- Electrospun Nanofibers in Biomedical Applications
- Pluripotent Stem Cells Research
- Congenital heart defects research
- Biomedical Ethics and Regulation
- Spinal Cord Injury Research
- Congenital Diaphragmatic Hernia Studies
- Cardiac Fibrosis and Remodeling
- Congenital Heart Disease Studies
- Receptor Mechanisms and Signaling
- Cardiovascular Disease and Adiposity
- Cardiac pacing and defibrillation studies
- Hematopoietic Stem Cell Transplantation
- COVID-19 Clinical Research Studies
- Frailty in Older Adults
- Neurological Disease Mechanisms and Treatments
University of Miami
2016-2025
Jackson Health System
2025
Bose (United States)
2024
Bay Area Medical Center
2024
Ziauddin University
2024
Mid Yorkshire Hospitals NHS Trust
2024
University of Birmingham
2023
Security Forces Hospital
2023
Quaid-i-Azam University
2023
Stem Cell Institute
2017-2022
Following the success obtained with transplantation of fresh human islets under steroid-free immunosuppression, this trial evaluated that had undergone a period in vitro culture and potential tumor necrosis factor (TNF-alpha) blockade to improve islet engraftment. Subjects included 16 patients type 1 diabetes mellitus (T1DM); half were randomly assigned receive Infliximab immediately preceding initial infusion. Immunosuppression consisted daclizumab induction sirolimus/tacrolimus...
Although human mesenchymal stem cells (hMSCs) have been tested in ischemic cardiomyopathy, few studies exist chronic nonischemic dilated cardiomyopathy (NIDCM).The authors conducted a randomized comparison of safety and efficacy autologous (auto) versus allogeneic (allo) bone marrow-derived hMSCs NIDCM.Thirty-seven patients were to either allo- or auto-hMSCs 1:1 ratio. Patients recruited between December 2011 July 2015 at the University Miami Hospital. received (100 million) by...
The rationale for implantation of autologous human Schwann cells (SCs) in persons with subacute spinal cord injury (SCI) is based on evidence that transplanted SCs are neuroprotective, support local axonal plasticity, and capable myelinating axons. A Phase I clinical trial was conducted to evaluate the safety SC transplantation into epicenter six subjects SCI. an open-label, unblinded, non-randomized, non-placebo controlled study a dose escalation design standard medical rehabilitation....
Rationale: Cell dose and concentration play crucial roles in phenotypic responses to cell-based therapy for heart failure. Objective: To compare the safety efficacy of 2 doses allogeneic bone marrow–derived human mesenchymal stem cells identically delivered patients with ischemic cardiomyopathy. Methods Results: Thirty cardiomyopathy received a blinded manner either 20 million (n=15) or 100 via transendocardial injection (0.5 cc per × 10 injections patient). Patients were followed 12 months...
Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for manufacture allogeneic purified human pancreatic islet (PHPI) product evaluated phase 3 trial subjects with type 1 diabetes. Manufacturing was controlled by common master production batch record, standard operating procedures that included acceptance criteria deceased donor organ pancreata...
While regional heterogeneity in islet distribution has been well studied rodents, less is known about human pancreatic histology. To fill gaps our understanding, differences the adult pancreas were quantitatively analyzed including pathogenesis of type 2 diabetes (T2D). Cadaveric specimens collected from head, body and tail regions each donor, subjects with no history or diseases (n = 23) as patients T2D 12). The study further included individuals whom islets isolated 7) to yield function a...
Aging frailty, characterized by decreased physical and immunological functioning, is associated with stem cell depletion. Human allogeneic mesenchymal cells (allo-hMSCs) exert immunomodulatory effects promote tissue repair. This a randomized, double-blinded, dose-finding study of intravenous allo-hMSCs (100 or 200-million [M]) vs placebo delivered to patients (n = 30, mean age 75.5 ± 7.3) frailty. The primary endpoint was incidence treatment-emergent serious adverse events (TE-SAEs) at...
Endothelial dysfunction, characterized by diminished endothelial progenitor cell (EPC) function and flow-mediated vasodilation (FMD), is a clinically significant feature of heart failure (HF). Mesenchymal stem cells (MSCs), which have pro-angiogenic properties, the potential to restore function. Accordingly, we tested hypothesis that MSCs increase EPC (FMD).Idiopathic dilated ischemic cardiomyopathy patients were randomly assigned receive autologous (n = 7) or allogeneic 15) MSCs. We...
Attaining glycemic targets without severe hypoglycemic events (SHEs) is a challenging treatment goal for patients with type 1 diabetes complicated by impaired awareness of hypoglycemia (IAH). The CIT Consortium Protocol 07 (CIT-07) trial showed islet transplantation to be an effective subjects IAH and intractable SHEs. We evaluated health-related quality life (HRQOL), functional health status, utility before after pancreatic in CIT-07 participants.Four surveys, the Diabetes Distress Scale...
Rationale: Autologous bone marrow mesenchymal stem cells (MSCs) and c-kit + cardiac progenitor (CPCs) are 2 promising cell types being evaluated for patients with heart failure (HF) secondary to ischemic cardiomyopathy. No information is available in humans about the relative efficacy of MSCs CPCs whether their combination more efficacious than either type alone. Objective: CONCERT-HF (Combination Mesenchymal Cardiac Stem Cells As Regenerative Therapy Heart Failure) a phase II trial aimed at...
A phase 1 open-label, non-randomized clinical trial was conducted to determine feasibility and safety of autologous human Schwann cell (ahSC) transplantation accompanied by rehabilitation in participants with chronic spinal cord injury (SCI). Magnetic resonance imaging (MRI) used screen eligible estimate an individualized volume suspension be implanted. The incorporated standardized multi-modal before after delivery. Participants underwent sural nerve harvest, ahSCs were isolated propagated...
Abstract Background Hematopoietic acute radiation syndrome (H-ARS) occurring after exposure to ionizing damages bone marrow causing cytopenias, increasing susceptibility infections and death. We others have shown that cellular therapies like human mesenchymal stromal cells (MSCs), or monocytes/macrophages educated ex-vivo with extracellular vesicles (EVs) from MSCs were effective in a lethal H-ARS mouse model. However, given the complexity of generating potential risks using allogeneic...
Schwann cell-derived extracellular vesicles (SCEVs) have demonstrated favorable effects in spinal cord, peripheral nerve, and brain injuries. Herein, a scalable, standardized, efficient isolation methodology of SCEVs obtaining high yield with consistent composition as measured by proteomic, lipidomic, miRNA analysis their content is described for future clinical use. Human cells were obtained ethically from nine donors cultured defined growth medium optimized proliferation. At confluency,...
Last year, from the approximately 6,000 organ donors, only 1,500 pancreata were used for clinical transplantation. Factors that contribute to this poor pancreas use include strict donor selection criteria and requirement short cold-ischemia time (CIT). Numerous have not been because of long ischemia times postprocurement. Given oxygen-rich environment islets in native pancreas, it is conceivable are highly susceptible irreversible damage following prolonged ischemia. The continuously...
Impaired endogenous stem cell repair capacity is hypothesized to be a biologic basis of frailty. Therapies that restore regenerative may therefore beneficial. This Phase 1 study evaluated the safety and potential efficacy intravenous, allogeneic, human mesenchymal (allo-hMSC)-based therapy in patients with aging In this nonrandomized, dose-escalation study, received single intravenous infusion allo-hMSCs: 20-million (n = 5), 100-million or 200-million cells 5). The primary endpoint was...
Culture-expanded cells originating from cardiac tissue that express the cell surface receptor cKit are undergoing clinical testing as a source for heart failure and congenital disease. Although accumulating data support mesenchymal stem (MSCs) enhance efficacy of cKit(+) (CSCs), underlying mechanism this synergistic effect remains incompletely understood.To test hypothesis MSCs stimulate endogenous CSCs to proliferate, migrate, differentiate via SDF1/CXCR4 factor/cKit pathways.Using genetic...
Mesenchymal stem cells (MSC) improve alveolar and vascular structures in experimental models of bronchopulmonary dysplasia (BPD). Female MSC secrete more anti-inflammatory pro-angiogenic factors as compared to male MSC. Whether the therapeutic efficacy attenuating lung injury an model BPD is influenced by sex donor or recipient unknown. Here we tested hypothesis that female would have greater regenerative properties than this benefit be evident males.To determine whether intra-tracheal (IT)...
Insufficient donor nerve graft material in peripheral surgery remains an obstacle for successful long-distance regeneration. Schwann cells (SCs) can be isolated from adult mammalian biopsies and grown culture retain their capacity to enhance regeneration within tubular repair strategies multiple animal models. Human (hSCs) isolated, expanded number, ability promote myelinate axons, but have never been tested a clinical case of injury. A sural biopsy tissue the traumatized sciatic stumps was...
Schwann cells are essential for the maintenance and function of motor neurons, axonal networks, neuromuscular junction. In amyotrophic lateral sclerosis, where neuron is progressively lost, cell may also be impaired. Recently, important signaling potential trophic activities cell-derived exosomal vesicles have been reported. This case report describes treatment a patient with advanced sclerosis using serial intravenous infusions allogeneic vesicles, marking, to our knowledge, first instance...
The relative inefficiency of the islet purification process may hamper obtaining enough islets for transplantation even with adequate pre-purification counts. In this study, we determined effect an additional step on total yields and pancreas utilization at our center.Twenty-five pancreata were processed using automated method followed by continuous gradient (CGP), less pure fractions sub-jected to rescue (RGP). CGP RGP combined transplanted into patients type 1 diabetes.CGP showed no...
In order to make islet transplantation a therapeutic option for patients with diabetes there is an urgent need more efficient cell processing maximize recovery. Improved donor management, organ recovery techniques, implementation of stringent criteria, and improved techniques may contribute enhance utilization transplantation. We have analyzed the effects factors on success rate human performed at single center. Islet isolation outcomes when vasopressors, in particular pitressin, steroids...
We report a water-soluble and non-toxic method to incorporate additional extracellular matrix proteins into gelatin hydrogels, while obviating the use of chemical crosslinkers such as glutaraldehyde.