Evaluation Of Cell Therapy Research Articles

Brain Organoids to Evaluate Cellular Therapies.

Animal models currently used to test the efficacy and safety of cell therapies, mainly murine models, have limitations as molecular, cellular, and physiological mechanisms are often inherently different between species, especially in the brain. Therefore, for clinical translation of cell-based medicinal products, the development of alternative models based on human neural cells may be crucial. We have developed an in vitro model of transplantation into human brain organoids to study the potential of neural stem cells as cell therapeutics and compared these data with standard xenograft studies in the brain of immunodeficient NOD.Cg-Prkdcscid Il2rgtm1Wjl/SzJ (NSG) mice. Neural stem cells showed similar differentiation and proliferation potentials in both human brain organoids and mouse brains. Our results suggest that brain organoids can be informative in the evaluation of cell therapies, helping to reduce the number of animals used for regulatory studies.

Evaluation of Cell Therapy on Exercise Performance and Limb Perfusion in Peripheral Artery Disease: The CCTRN Patients with Intermittent Claudication Injected with ALDH Bright Cells (PACE) Trial

Local injection of autologous bone marrow-derived aldehyde dehydrogenase bright (ALDHbr) cells (in the dosage and manner described) into the thigh and calf of patients with claudication does not improve peak walking disease (PWT) or magnetic resonance imaging (MRI) capillary perfusion nor were there demonstrated quality of life (QOL) improvements. In patients with completely occluded superficial femoral arteries, the number of collateral arteries did increase with ALDHbr cell injection on post hoc analysis, which suggests a potential benefit in those with more advanced disease.

The usability of quantification of myocardial blood flow by cardiac magnetic resonance for evaluation of cell therapy for ischemic cardiomyopathy using a retrograde injection method

Methods The candidate of this study was 5 cases of ICM (All Male, 64.3 + 7.7 y/o). Bone marrow Mononuclear cells (BMMNC) were quickly injected retrogradely via the coronary vein into the myocardium of LAD area through the infusion catheter. The number of injected BMMNC is 1.47 + 0.35 × 108. P-MRI and SPECT were performed before and after procedure. P-MRI was obtained with a saturation recovery balanced TFE sequence, by injecting 0.05 mmol/ kg of Gd-DTPA during vasodilator stress and at rest. Dual bolus method was used to correct for blood saturation. Absolute MBF was quantified by using a model based Patlak analysis, with correction for flow-dependent alteration in extraction fraction of Gd-DTPA. Therapy evaluation were made, which were 1) Symptom of Angina pectoris with CCS scoring. 2) SPECT score: Summed rest Score (SRS), Summed stress score (SSS), Summed Difference Score (SDS). 3) BMF and Coronary Flow Reserve (CFR) from P-MRI.

The emergence of cell therapy in France. Public health, regulations and other controversial issues.

Cell therapy can be defined as the in vivo use of autologous, allogeneic or xenogeneic cells for the prevention, treatment or attenuation of disease. The definition of cell therapy products has been the source of a recent controversy in France. Presently, cell therapy is associated with biological products and manufacturing processes which are frequently poorly defined. A stringent evaluation of cell therapy, as well as the establishment of an optimal regulatory environment, are therefore justified. In France, a recent law (05.28.96) defines cell therapy products as biological products with therapeutic purpose. Cell therapy centers will receive an agreement from the Health Ministry. The French Drug Agency will have responsibility for clinical protocol approval and monitoring, as well as ensure overall quality control. Hopefully, these decisions will contribute to the emergence of cell therapy as a well established, high quality, therapeutic procedure.

An evaluation of cell therapy in Down syndrome

A group of children with Down syndrome who were being treated with cell therapy was matched for age and sex with an untreated control group. Comparisons were made between the groups with respect to a number of developmental and physical variables which have been reported to be influenced by cell therapy. Of 55 comparisons made between treated and control groups, two differences were statistically significant. This study failed to show sufficient significant results for the treatment to be regarded as effective.