PSC-01 / Personalized Stem Cells - LARVOL DELTA

Clinical Evaluation of Safety and Efficacy of a Central cGMP Laboratory Produced Autologous Adipose-derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis. (PubMed, Stem Cells Dev) - "Unique to this study of autologous cells is the shipment of lipoaspirate from the clinic to a central FDA-compliant manufacturing facility for cleanroom-controlled manufacturing. The cell product characterization data demonstrates that this method produces an equivalent product in terms of cell count and viability with the added benefit of further quality assurance testing including sterility, endotoxin, and flow cytometry prior to patient administration."

Journal • Stroma • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Personalized Stem Cells Announces Stem Cell Knee Arthritis FDA-Approved Phase 1/2a Clinical Trial Results (EIN News) - P1/2, N=39; "Personalized Stem Cells...announces the results of its single knee osteoarthritis phase 1/2a clinical trial. The final study report has been submitted to the FDA for review and in support of a full scale randomized controlled trial to be conducted later this year....Safety was the primary objective of this study and there were no serious adverse events reported. The efficacy of the experimental cell therapy in knee osteoarthritis was measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and showed that 79.3% of the patients improved above the 'minimal important change' (MIC) with an average improvement over baseline of 2.2 times the MIC...There were 39 participants in the study enrolled across seven sites in the US."

P1/2 data • CNS Disorders • Osteoarthritis • Pain

Personalized Stem Cells Announces Treatment Milestone for FDA Approved Stem Cell Clinical Trial for Knee Arthritis (EIN News) - "Personalized Stem Cells, Inc (PSC)...announces that all clinical trial participants have received treatment in the FDA approved stem cell clinical trial for treatment of knee osteoarthritis. This treatment milestone comes just two months after the company announced the trial was fully enrolled. Clinical trial participants received one injection of their own stem cells into the affected knee....PSC aims to compile and submit clinical study data to the FDA in the first quarter of 2021, after which a Phase 2 blinded, placebo-controlled study will be launched. While Phase 1 studies focus on safety, the emphasis of Phase 2 studies is on effectiveness."

New P2 trial • P1 data • Trial status • CNS Disorders • Osteoarthritis • Pain

Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis (clinicaltrials.gov) - P1; N=125; Active, not recruiting; Sponsor: Personalized Stem Cells, Inc.; Trial completion date: Aug 2020 ➔ Jan 2021; Trial primary completion date: Aug 2020 ➔ Jan 2021

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

Personalized Stem Cells Announces Completion of Enrollment for FDA Approved Stem Cell Clinical Trial for Knee Arthritis (PRNewswire) - "Personalized Stem Cells, Inc (PSC)...has announced that enrollment is officially complete for their FDA approved stem cell clinical trial for treatment of knee osteoarthritis. 38 patients are participating in the clinical trial to have one knee treated with their own stem cells....PSC aims to compile and submit clinical study data to the FDA by the end of 2020 after which a Phase II blinded, placebo-controlled study will be launched."

Enrollment closed • New P2 trial • Osteoarthritis • Pain

Personalized Stem Cells, Inc. proceeds with stem cell trial for knee osteoarthritis (EIN Presswire) - "Personalized Stem Cells, Inc (PSC), a human adipose-derived stem cell company, has continued enrollment for participation in an FDA approved clinical trial for stem cell treatment of knee osteoarthritis. Though the trial never stopped, in-person visits were halted, and telemedicine was employed per the new FDA guidelines."

Enrollment status • Osteoarthritis • Pain

Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis (clinicaltrials.gov) - P1; N=125; Active, not recruiting; Sponsor: Personalized Stem Cells, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis (clinicaltrials.gov) - P1; N=125; Recruiting; Sponsor: Personalized Stem Cells, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Personalized Stem Cells, Inc. announces first patients treated in FDA approved clinical trial for treatment of osteoarthritis with stem cells (PRWeb) - "Personalized Stem Cells, Inc...has successfully enrolled the first patients in an FDA approved clinical trial for stem cell treatment of knee osteoarthritis....This is the first of several planned clinical trials which will enable qualified PSC-enrolled physicians to provide FDA compliant, quality cell therapy to patients suffering from osteoarthritis."

Enrollment status

Personalized Stem Cells, Inc. announces first patients enrolled in FDA approved clinical trial for treatment of osteoarthritis with stem cells (PRWeb) - "Personalized Stem Cells, Inc...has successfully enrolled the first patient in an FDA approved clinical trial for stem cell treatment of knee osteoarthritis. The successful enrollment comes only a little more than one year after formation of the company as a subsidiary of VetStem Biopharma....Additional clinical trial sites are anticipated in Q4 2019 and early 2020."

Enrollment status