Nuts and Bolts of Planning MSC Clinical Trials
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1 Nuts and Bolts of Planning MSC Clinical Trials Lawrence Couture, City of Hope Robert Deans, Athersys Robert Preti, Progenitor Cell Therapy EJ Read, Blood Systems Research Institute
2 Workshop Discussion Points A heavy emphasis has been placed on translation research initiatives by state governments and federal agencies Many investigators with basic research findings are looking for a path from bench to bedside Institutions vary in terms of guidance translational research, and networks to assist in therapeutic cell production, Regulatory communication, financial support for Phase I proof of concept studies.
3 MSC Translational Progress Clinical Proof of Concept First 10 Years Lazarus [Bone Marrow Transplant (1995) 16:557] Horwitz [Nature Medicine (1999) 5:309] Osiris Phase I autologous, allogeneic MSC in transplant setting Efficacy Trials Second 10 Years Placebo controlled studies Branching Regulatory strategies broad translational exploration Alternate models for practicing therapy clinical consortia and industry Broad Translational Exploration Underway Deans ISCT 2009
4 Osiris Development Path: Immunomodulation HSC transplant Ph I, II 46 patients Doses: 1, 2.5, 5 mpk GI GvHD / Crohn s [Planned, not executed GI GvHD Ph I II] Crohns Ph II 10 patients Doses: 2, 8 mpk 4 sites Biologic refractory Crohns Ph III 258 patients Doses: 600MM 4inf 2wks 50 sites Steroid refractory GvHD Pediatric compassionate use 6 patients Ph II Ph III 14 patients 240 patients 8 mpk/inf every3d max8 2inf/wk 4wks 80 sites Acute GvHD Ph II 32 patients 16 sites Dosing: 2, 8 mpk; 2 infusions, 3d apart Ph III 184 patients Dosing: 2 mpk/inf; 6 infusions 50 sites Type I Diabetes COPD AMI Early onset T1 Ph II 60 patients 3 infusion / 60 days Ph II 60 patients Deans ISCT 2009
5 Dominici, M., et al (2006) Minimal criteria for defining multipotent mesenchymal stromal cells Cytotherapy 8: Lot Release Expectations Sterility Viability, Identity, Purity CD105, CD73 positive CD45, class II HLA negative Potency Differentiation into multiple mesenchymal lineages (bone, fat, cartilage) Karyotype normal stable karyotype N = 3 or greater to qualify process Product can be released to patient while final sterility testing is completed, provided appropriate corrective actions are in place
6 Discussion Points
7 Clinical Manufacturing Discussion Advantages and differences between cell manufacturing and contract services Private sector Academic cell processing centers Vector production and integration into clinical manufacturing How to bring partners together Process transfer and qualification requirements What works and what doesn t Accessing experience Master file referencing Who owns the IND?
8 Regulatory Discussion What s in an IND package? How can one receive FDA feedback in advance of IND filing? What are patient data and safety monitoring requirements, and what support infrastructure can be accessed? What additional considerations are required for gene therapy protocols? What are the patient data and safety monitoring requirements, and what support infracstructure can be accessed? How can multicenter trials be managed in the context of multiple cell processing production centers?
9 Trial Design and Logistics How should pre clinical efficacy and safety study requirements integrate with clinical dosing and administration What institutional review committees are required? IRB, Scientific Committees, RAC How is patient safety and data oversight managed at your institution? How do stem cell processing centers integrate with other departments for cell dosing and infusion?
10 What are the costs and how can they be managed? Cost centers Manufacturing Patient treatment, monitoring Patient follow up costs outside of standard of care Physician oversight Indemnity Where can funding be obtained for clinical studies? EU Framework Programs NIH, NHLBI PACT CIRM Foundations industry
11
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