Elixcyte (adipose derived allogenic stem cell therapy) / UnicoCell Biomed - LARVOL DELTA

ELIXCYTE®, an Allogenic Adipose-Derived Stem Cell Product, Mitigates Osteoarthritis by Reducing Inflammation and Preventing Cartilage Degradation In Vitro. (PubMed, Curr Issues Mol Biol) - "ELIXCYTE® treatment elevated anti-inflammatory cytokine (IL-1RA, IL-10, and IL-13) levels, and the reduction in MMP13 was positively correlated with IL-11 concentrations in OA-SF. These findings indicate that IL-11 in OA-SF might serve as a predictive biomarker for the ELIXCYTE® treatment response in OA, emphasizing the therapeutic potential of ELIXCYTE® to mitigate OA progression and provide insights into its immunomodulatory effects."

Journal • Preclinical • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology • FGF2 • IL10 • IL13 • IL1R1 • MMP13 • PACERR • PTGS2

Efficacy and Safety of ELIXCYTE Intra-articular Injection in Subject With Knee Osteoarthritis (clinicaltrials.gov) - P3 | N=165 | Recruiting | Sponsor: UnicoCell Biomed CO. LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

Adipose-derived Stem Cells (ADSCs) for Moderate to Severe Chronic Kidney Disease (clinicaltrials.gov) - P1/2 | N=39 | Completed | Sponsor: UnicoCell Biomed CO. LTD | Recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

【Announcement】The first subject of Phase III clinical trial of Xiangrong Biotechnology's new adipose stem cell drug ELIXCYTE in the treatment of knee osteoarthritis (Knee Osteoarthritis) has been accepted. [Google tanslation] (stock.yahoo) - "The first subject of the Phase III clinical trial of Xiangrong Biotechnology's new adipose stem cell drug ELIXCYTE in the treatment of knee osteoarthritis (Knee Osteoarthritis) has completed the case....The clinical trial case was completed on July 10, 2012 at Linkou Chang Gung Hospital and the first subject was accepted."

Trial status • CNS Disorders • Immunology • Osteoarthritis

[Announcement] Xiangrong Biotechnology's new adipose-derived stem cell drug ELIXCYTE has been approved by the US Food and Drug Administration (US FDA) to perform Phase III clinical trials for the treatment of knee osteoarthritis (Knee Osteoarthritis). [Google translation] (Yahoo News) - "Xiangrong Biotechnology's new adipose stem cell drug ELIXCYTE has been approved by the US Food and Drug Administration (US FDA) to perform Phase III clinical trials for the treatment of knee osteoarthritis (Knee Osteoarthritis)."

IND • New P3 trial • CNS Disorders • Osteoarthritis • Pain

【Announcement】Xiangrong Biotechnology's new drug ELIXCYTE for the treatment of knee osteoarthritis phase III clinical trial has been approved by the Ministry of Health and Welfare [Google translation] (Yahoo News) - “Xiangrong Biotech's new fat stem cell drug ELIXCYTE in the treatment of knee osteoarthritis Phase III clinical trial case approved by the Ministry of Health and Welfare”

New P3 trial • CNS Disorders • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology

Efficacy and Safety of ELIXCYTE Intra-articular Injection in Subject With Knee Osteoarthritis (clinicaltrials.gov) - P3 | N=165 | Not yet recruiting | Sponsor: UnicoCell Biomed CO. LTD

New P3 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Allogeneic adipose tissue-derived stem cells ELIXCYTE in chronic kidney disease: A phase I study assessing safety and clinical feasibility. (PubMed, J Cell Mol Med) - "No significant reduction in proteinuria was noted among all subjects. This phase I trial demonstrated single-dose intravenous ELIXCYTE was well tolerated in moderate-to-severe CKD patients and its preliminary efficacy warrants future studies."

Journal • P1 data • Chronic Kidney Disease • Nephrology • Renal Disease

Treatment of knee osteoarthritis with intra-articular injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE®: a phase I/II, randomized, active-control, single-blind, multiple-center clinical trial. (PubMed, Stem Cell Res Ther) - P1/2 | "ELIXCYTE® for knee osteoarthritis treatment was effective, safe, and well-tolerated. The efficacy results were showed that ELIXCYTE® conferred the earlier onset of reductions in pain scores and improvements in functional scores than HA group."

Clinical • Journal • P1/2 data • Immunology • Osteoarthritis • Pain • Rheumatology

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis (clinicaltrials.gov) - P1/2; N=57; Completed; Sponsor: UnicoCell Biomed CO. LTD; Active, not recruiting ➔ Completed; Trial completion date: Apr 2022 ➔ Jun 2021

Clinical • Trial completion • Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology • MRI

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis (clinicaltrials.gov) - P1/2; N=57; Active, not recruiting; Sponsor: UnicoCell Biomed CO. LTD; Trial completion date: Dec 2020 ➔ Apr 2022

Clinical • Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology • MRI

Adipose-derived Stem Cells (ADSCs) for Moderate to Severe Chronic Kidney Disease (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: UnicoCell Biomed CO. LTD; N=36 ➔ 90

Clinical • Enrollment change • Chronic Kidney Disease • Nephrology • Renal Disease • CST3 • FABP1 • IL18 • KIM1 • LCN2

Adipose-derived Stem Cells (ADSCs) for Moderate to Severe Chronic Kidney Disease (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: UnicoCell Biomed CO. LTD; Trial completion date: Jun 2021 ➔ Jan 2022

Clinical • Trial completion date

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis (clinicaltrials.gov) - P1/2; N=57; Active, not recruiting; Sponsor: UnicoCell Biomed CO. LTD; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2019 ➔ Dec 2020

Clinical • Enrollment closed • Trial completion date

Adipose-derived Stem Cells (ADSCs) for Moderate to Severe Chronic Kidney Disease (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: UnicoCell Biomed CO. LTD; Trial completion date: Dec 2019 ➔ Jun 2021; Trial primary completion date: Aug 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: UnicoCell Biomed CO. LTD; Trial primary completion date: Dec 2018 ➔ Jul 2019

Clinical • Trial primary completion date