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Intra-arterial renal infusion of autologous mesenchymal stem cells for treatment of chronic kidney disease in cats: Phase I clinical trial.

ABSTRACT: BACKGROUND:There are no known treatments that halt or reverse chronic kidney disease (CKD) in cats. In rodent models, stem cell treatment has been associated with improvement in renal function parameters, especially when stem cells were delivered intra-arterially to the kidney. To date, only IV and intrarenal stem cell infusions have been studied in cats with CKD with no clinically relevant improvement noted. OBJECTIVE:To assess the safety and feasibility of intra-arterial delivery of autologous mesenchymal stem cells (MSC) in stromal vascular fraction (SVF) to the kidney in cats with CKD. ANIMALS:Five client-owned domestic cats with International Renal Interest Society stage III CKD. METHODS:Prospective cohort study (phase I clinical trial). Adipose tissue was harvested from study animals on day 0. On days 2 and 14, an infusion of MSC in SVF was administered into the renal artery via the femoral or carotid artery using fluoroscopic guidance. Serum creatinine and blood urea nitrogen concentration, plasma iohexol clearance, and quality of life assessments were monitored between days 0 and 90. RESULTS:The procedure was performed successfully in all cats. No severe adverse events were observed in any cat during the study period. CONCLUSIONS AND CLINICAL IMPORTANCE:Intra-arterial infusion of MSC into the renal artery in CKD cats was feasible and safe within a 3-month postoperative period. Efficacy and long-term safety have yet to be established. This procedure requires careful technique and training.

SUBMITTER: Thomson AL

PROVIDER: S-EPMC6524114 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Intra-arterial renal infusion of autologous mesenchymal stem cells for treatment of chronic kidney disease in cats: Phase I clinical trial.

Thomson Abigail L AL Berent Allyson C AC Weisse Chick C Langston Catherine E CE

Journal of veterinary internal medicine 20190329 3

<h4>Background</h4>There are no known treatments that halt or reverse chronic kidney disease (CKD) in cats. In rodent models, stem cell treatment has been associated with improvement in renal function parameters, especially when stem cells were delivered intra-arterially to the kidney. To date, only IV and intrarenal stem cell infusions have been studied in cats with CKD with no clinically relevant improvement noted.<h4>Objective</h4>To assess the safety and feasibility of intra-arterial deliver ...[more]

PMID: 30924554

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Project description:Background and objectivesChronic obstructive pulmonary disease (COPD) is characterized by the destruction of alveolar walls, chronic inflammation and persistent respiratory symptoms. There is no curative clinical treatment for COPD. In this context, cell-based therapy is a promising therapeutic alternative for COPD. Thus, in this open, controlled and randomized Phase I Clinical Trial, we aimed to assess the safety of the infusion of autologous bone marrow mononuclear cells (BMMC), adipose-derived mesenchymal stromal cells (ADSC) and, especially, the safety of concomitant infusion (co-infusion) of BMMC and ADSC as a new therapeutic alternative for COPD. The rationale for co-infusion of BMMC and ADSC is based on the hypothesis of an additive or synergistic therapeutic effect resulting from this association.MethodsTo achieve the proposed objectives, twenty patients with moderate-to-severe COPD were randomly divided into four groups: control group - patients receiving conventional treatment; BMMC group - patients receiving only BMMC; ADSC group - patients receiving only ADSC, and co-infusion group - patients receiving the concomitant infusion of BMMC and ADSC. Patients were assessed for pulmonary function, biochemical profile, and quality of life over a 12 months follow-up.ResultsNo adverse events were detected immediately after the infusion of BMMC, ADSC or co-infusion. In the 12-month follow-up, no causal relationship was established between adverse events and cell therapy procedures. Regarding the efficacy, the BMMC group showed an increase in forced expiratory volume (FEV1) and diffusing capacity for carbon monoxide (DLCO). Co-infusion group showed a DLCO, and gas exchange improvement and a better quality of life.ConclusionThe results obtained allow us to conclude that cell-based therapy with co-infusion of BMMC and ADSC is a safe procedure and a promising therapeutic for COPD. However, additional studies with a greater number of patients are needed before randomized and controlled Phase III clinical trials can be implemented.

Project description:BackgroundDelta-24-RGD, an oncolytic adenovirus, shows promise against glioblastoma. To enhance virus delivery, we recently demonstrated that human bone marrow-derived mesenchymal stem cells loaded with Delta-24-RGD (hMSC-D24) can eradicate glioblastomas in mouse models. There are no studies examining the safety of endovascular selective intra-arterial (ESIA) infusions of MSC-D24 in large animals simulating human clinical situations.ObjectiveTo perform canine preclinical studies testing the feasibility and safety of delivering increasing doses of hMSCs-D24 via ESIA infusions.MethodsESIA infusions of hMSC-D24 were performed in the cerebral circulation of 10 normal canines in the target vessels (internal carotid artery [ICA]/P1) via transfemoral approach using commercially available microcatheters. Increasing concentrations of hMSC-D24 or particles (as a positive control) were injected into 1 hemisphere; saline (negative control) was infused contralaterally. Toxicity (particularly embolic stroke) was assessed on postinfusion angiography, diffusion-weighted magnetic resonance imaging, clinical exam, and necropsy.ResultsESIA injections were performed in the ICA (n = 7) or P1 (n = 3). In 2 animals injected with particles (positive control), strokes were detected by all assays. Of 6 canines injected with hMSC-D24 through the anterior circulation, escalating dose from 2 × 106 cells/20 mL to 1 × 108 cells/10 mL resulted in no strokes. Two animals had ischemic and hemorrhagic strokes after posterior cerebral artery catheterization. A survival experiment of 2 subjects resulted in no complications detected for 24-h before euthanization.ConclusionThis novel study simulating ESIA infusion demonstrates that MSCs-D24 can be infused safely at least up to doses of 1 × 108 cells/10 mL (107 cells/ml) in the canine anterior circulation using commercially available microcatheters. These findings support a clinical trial of ESIA infusion of hMSCs-D24.

Dataset Information

Intra-arterial renal infusion of autologous mesenchymal stem cells for treatment of chronic kidney disease in cats: Phase I clinical trial.

Publications

Intra-arterial renal infusion of autologous mesenchymal stem cells for treatment of chronic kidney disease in cats: Phase I clinical trial.

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