STEM CELL EXPERIENCE

With over 10 years of combined stem cell experience, PSC Clinical can confidently provide a specialized staff to assist any company with compliance, regulatory or quality assurance needs.  Our stem cell experts have worked extensively with several stem cell clinical trials by developing protocols, analyzing data, writing reports for submission to the FDA, managing Serious Adverse Events (SAEs), performing quality control on stem cell products, and providing monitoring and auditing services.  In addition to expertise, PSC Clinical also has a passion for stem cell research and the future medical innovations it has the potential to provide.

PSC Clinical's stem cell clinical trial experience includes:

A PIlot Trial of Unreleated Umbilical Cord Blood Transplantation (UCBT) Augmented with Cytokine-Primed Aldehyde Dehydrogenase-Bright Cells

A Phase I-II Randomized Comparison of Autologous Bone Marrow Derived Aldehyde Dehydrogenase-Bright Enriched Mononuclear Cells RAndomized Against Unfractionated Autologous Mononuclear one Marrow in Patients with Rutherford 4 or 5 Peripheral Arterial Occlusive Disease

A Phase 1b/2a Dose-escalation Study to Assess the Safety and Feasibility of Transendocardial Delivery of 3 Different Doses of Alogeneic Mesenchymal Precursor Cells (MPCs) in subjects with recent Acute Myocardial Infarction

Transplantation in Myocardial Infarction Evaluation Protocol - A Phase II, Randomized, Controlled, Double-Blind Trial Evaluating the Effect of Timin on the Administration of Bone Marrow Mononuclear Cells (BMMNCs) versus Placebo in Patients with Acute Myocardial Infarction

Inramyocardial Injection of Autologous Bone Marrow Mononuclear Cells under Electromechanical Guidance for Patients with Chronic Ischemic Heart Disease and Left Ventricular Dysfunction

A Phase one study of regulatory T cell depletion with Denileukin Diftitox followed by Active Immunotherapy with Autologous Dendritic Cells Infected with CEA-6D Expressing Fowlpox-TRICOM in patients with Advanced or Metastatic Malignancies Expressing CEA

Randomized trial of Safety and Efficacy of Donor Lymphocyte Infusions from 6/6 HLA Matched Family Members for Hematologic Malignancies or Solid Tumors

A Pilot Clinical Trial of CMV pp65 Specific T cell Adoptive Immunotherapy in Patients Who Have Undergone Non-myeloablative Allogeneic Stem Cell Transplantation

Intensive Induction Therapy followed by Early High Dose Chemotherapy and BMT for Mantle Cell Lymphoma

Safety Trial of NK Cell DLIs from 3-5/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation

Safety Trial of NK Cell DLIs from 6/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation