- |||||||||| emiplacel (PLX-PAD) - Pluri, Charite / University of Medicine Berlin
Trial termination: Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19 (clinicaltrials.gov) - Oct 11, 2023 P2a, N=23, Terminated, Trial registration: NCT03006770 (http://www.clinicaltrials.gov); 2015-005532-18 (EudraCT Clinical Trials register - Search for 2015-005532-18). Active, not recruiting --> Terminated; The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.
- |||||||||| emiplacel (PLX-PAD) - Pluri, Charite / University of Medicine Berlin
Trial completion date, Trial termination: Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19 (clinicaltrials.gov) - Oct 10, 2023 P2, N=66, Terminated, Active, not recruiting --> Terminated; The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients. Trial completion date: Feb 2023 --> Jun 2023 | Active, not recruiting --> Terminated; The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients
- |||||||||| emiplacel (PLX-PAD) - Pluri, Charite / University of Medicine Berlin
Trial completion: Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF) (clinicaltrials.gov) - Sep 28, 2023 P3, N=240, Completed, Trial completion date: Feb 2023 --> Jun 2023 | Active, not recruiting --> Terminated; The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients Active, not recruiting --> Completed
- |||||||||| avoplacel (PLX-R18) / Pluristem
Biomarker, Preclinical, Journal: Pre-Administration of PLX-R18 Cells Protects Mice from Radiation-Induced Hematopoietic Failure and Lethality. (Pubmed Central) - Oct 28, 2022 PLX-R18 administration attenuated biomarkers of bone marrow aplasia (EPO, FLT3L), sepsis (SAA), and systemic inflammation (sP-selectin and E-selectin) and attenuated radiation-induced inflammatory cytokines/chemokines and growth factors, including G-CSF, MIP-1a, MIP-1b, IL-2, IL-6 and MCP-1, In addition, PLX-R18 also ameliorated radiation-induced upregulation of pAKT. Taken together, prophylactic PLX-R18 administration may serve as a protection measure, mitigating bone marrow failure symptoms and systemic inflammation in the H-ARS model.
- |||||||||| emiplacel (PLX-PAD) - Pluristem, Charite / University of Medicine Berlin
Preclinical, Journal: Placenta-Derived Mesenchymal-like Adherent Stromal Cells as an Effective Cell Therapy for Cocaine Addiction in a Rat Model. (Pubmed Central) - Jul 29, 2022 We found that PLX-PAD cells attenuated cocaine-seeking behavior through their capacity to migrate to specific mesolimbic regions, homed on the parenchyma in the dentate gyrus of the hippocampus, and restored neurogenesis. We believe that intranasal cell therapy is a safe and effective approach to treating addiction and may offer a novel and efficient approach to rehabilitation.
- |||||||||| emiplacel (PLX-PAD) - Pluri, Charite / University of Medicine Berlin
Enrollment closed, Trial completion date, Trial primary completion date: Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF) (clinicaltrials.gov) - Dec 1, 2021 P3, N=240, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Nov 2023 | Trial primary completion date: Jun 2021 --> May 2022
- |||||||||| emiplacel (PLX-PAD) - Pluristem, Charite / University of Medicine Berlin
Preclinical, Journal: Placenta-Expanded Stromal Cell Therapy in a Rodent Model of Simulated Weightlessness. (Pubmed Central) - Oct 22, 2021 Clinically relevant, human placenta-derived therapeutic stromal cells (PLX-PAD) are a promising therapeutic alternative...These findings support the therapeutic potential of placenta-derived stromal cells for select physiological deficits during simulated spaceflight. Multiple countermeasures are likely needed for comprehensive protection from the deleterious effects of prolonged spaceflight.
- |||||||||| emiplacel (PLX-PAD) - Pluri, Charite / University of Medicine Berlin
Enrollment closed, Enrollment change, Trial completion date: Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19 (clinicaltrials.gov) - Aug 10, 2021 P2, N=66, Active, not recruiting, Multiple countermeasures are likely needed for comprehensive protection from the deleterious effects of prolonged spaceflight. Recruiting --> Active, not recruiting | N=140 --> 66 | Trial completion date: Mar 2022 --> Jun 2022
- |||||||||| emiplacel (PLX-PAD) - Pluri, Charite / University of Medicine Berlin
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19 (clinicaltrials.gov) - Aug 10, 2021 P2a, N=23, Active, not recruiting, Recruiting --> Active, not recruiting | N=140 --> 66 | Trial completion date: Mar 2022 --> Jun 2022 Recruiting --> Active, not recruiting | N=40 --> 23 | Trial completion date: Mar 2022 --> Sep 2022 | Trial primary completion date: May 2021 --> Aug 2021
- |||||||||| emiplacel (PLX-PAD) - Pluristem, Charite / University of Medicine Berlin
Enrollment closed, Trial completion date, Trial primary completion date: Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization (clinicaltrials.gov) - Dec 28, 2020 P3, N=213, Active, not recruiting, Our results emphasize the importance of understanding the cell origin and characteristics in order to obtain a desired result, such as modulation of the inflammatory response that is critical in fostering regenerative processes. Recruiting --> Active, not recruiting | Trial completion date: Mar 2022 --> Mar 2021 | Trial primary completion date: Dec 2021 --> Mar 2021
- |||||||||| emiplacel (PLX-PAD) - Pluri, Charite / University of Medicine Berlin
Trial completion date, Trial primary completion date: Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19 (clinicaltrials.gov) - Oct 28, 2020 P2, N=140, Recruiting, Other attractive clinical areas for PLX-R18 therapy include acute radiation syndrome, bone marrow failure, aplastic anemia, myelofibrosis and with HCT as a “pan” cytokine to enhance rapid count recovery in all cells lines. Trial completion date: Dec 2021 --> Mar 2022 | Trial primary completion date: Dec 2020 --> May 2021
- |||||||||| avoplacel (PLX-R18) / Pluristem
Journal: Use of MSCs and MSC-educated macrophages to mitigate hematopoietic acute radiation syndrome. (Pubmed Central) - Sep 20, 2020 Although MSCs, MEMs and EEMs are potential cell therapy candidates in promoting hematopoietic HRS, challenges persist in translational clinical development of these products to the clinic. Whether any of these cellular therapies will be sufficient as stand-alone therapies to mitigate H-ARS or if they will be a bridging therapy that insures survival until a curative allogeneic hematopoietic stem cell transplant can be performed are the key questions that will have to be answered.
- |||||||||| emiplacel (PLX-PAD) - Pluri, Charite / University of Medicine Berlin
Trial completion date, Trial primary completion date: Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF) (clinicaltrials.gov) - Aug 8, 2020 P3, N=240, Recruiting, Trial completion date: Jun 2020 --> Aug 2021 | Trial primary completion date: Jun 2020 --> Aug 2021 Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Jun 2021
- |||||||||| emiplacel (PLX-PAD) / Pluristem
Preclinical, Journal: Use of Human Placenta-Derived Cells in a Preclinical Model of Tendon Injury. (Pubmed Central) - Jan 21, 2020 Not yet recruiting --> Recruiting Human extraembryonic tissues, such as the placenta, are an emerging source of cells for musculoskeletal repair and may hold promise as a point-of-care cell therapy for tendon injuries.
- |||||||||| emiplacel (PLX-PAD) / Pluristem
Journal: PLX-PAD Cell Treatment of Critical Limb Ischaemia: Rationale and Design of the PACE Trial. (Pubmed Central) - Jun 15, 2019 P3 Based on favourable pre-clinical and initial clinical study results, the PACE phase III randomised controlled trial will evaluate placenta derived PLX-PAD cell treatment in patients with critical limb ischaemia, with an unfavourable risk benefit for revascularisation. Clinicaltrials.gov: NCT03006770.
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