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The Interdisciplinary Stem Cell Institute's Use of Food and Drug Administration-Expanded Access Guidelines to Provide Experimental Cell Therapy to Patients With Rare Serious Diseases.
Khan A, Bellio MA, Schulman IH, Levi AD, Longsomboon B, Brooks A, Valasaki K, DiFede DL, Pujol MV, Yavagal DR, Bates KE, Si MS, Kaushal S, Green BA, Anderson KD, Guest JD, Burks SS, Silvera R, Santamaria AJ, Lalwani A, Dietrich WD, Hare JM. Khan A, et al. Among authors: difede dl. Front Cell Dev Biol. 2021 Jun 8;9:675738. doi: 10.3389/fcell.2021.675738. eCollection 2021. Front Cell Dev Biol. 2021. PMID: 34169074 Free PMC article.
Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty.
Golpanian S, DiFede DL, Pujol MV, Lowery MH, Levis-Dusseau S, Goldstein BJ, Schulman IH, Longsomboon B, Wolf A, Khan A, Heldman AW, Goldschmidt-Clermont PJ, Hare JM. Golpanian S, et al. Among authors: difede dl. Oncotarget. 2016 Mar 15;7(11):11899-912. doi: 10.18632/oncotarget.7727. Oncotarget. 2016. PMID: 26933813 Free PMC article. Clinical Trial.
Rationale and design of the Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Dilated Cardiomyopathy (the POSEIDON-DCM study): a phase I/II, randomized pilot study of the comparative safety and efficacy of transendocardial injection of autologous mesenchymal stem cell vs. allogeneic mesenchymal stem cells in patients with non-ischemic dilated cardiomyopathy.
Mushtaq M, DiFede DL, Golpanian S, Khan A, Gomes SA, Mendizabal A, Heldman AW, Hare JM. Mushtaq M, et al. Among authors: difede dl. J Cardiovasc Transl Res. 2014 Dec;7(9):769-80. doi: 10.1007/s12265-014-9594-0. Epub 2014 Oct 30. J Cardiovasc Transl Res. 2014. PMID: 25354998 Free PMC article. Clinical Trial.
Concise Review: Review and Perspective of Cell Dosage and Routes of Administration From Preclinical and Clinical Studies of Stem Cell Therapy for Heart Disease.
Golpanian S, Schulman IH, Ebert RF, Heldman AW, DiFede DL, Yang PC, Wu JC, Bolli R, Perin EC, Moyé L, Simari RD, Wolf A, Hare JM; Cardiovascular Cell Therapy Research Network. Golpanian S, et al. Among authors: difede dl. Stem Cells Transl Med. 2016 Feb;5(2):186-91. doi: 10.5966/sctm.2015-0101. Epub 2015 Dec 18. Stem Cells Transl Med. 2016. PMID: 26683870 Free PMC article. Review.
Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty.
Golpanian S, DiFede DL, Khan A, Schulman IH, Landin AM, Tompkins BA, Heldman AW, Miki R, Goldstein BJ, Mushtaq M, Levis-Dusseau S, Byrnes JJ, Lowery M, Natsumeda M, Delgado C, Saltzman R, Vidro-Casiano M, Pujol MV, Da Fonseca M, Oliva AA Jr, Green G, Premer C, Medina A, Valasaki K, Florea V, Anderson E, El-Khorazaty J, Mendizabal A, Goldschmidt-Clermont PJ, Hare JM. Golpanian S, et al. Among authors: difede dl. J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1505-1512. doi: 10.1093/gerona/glx056. J Gerontol A Biol Sci Med Sci. 2017. PMID: 28444181 Free PMC article. Clinical Trial.
Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study).
Florea V, Rieger AC, DiFede DL, El-Khorazaty J, Natsumeda M, Banerjee MN, Tompkins BA, Khan A, Schulman IH, Landin AM, Mushtaq M, Golpanian S, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Valasaki K, Pujol MV, Ghersin E, Miki R, Delgado C, Abuzeid F, Vidro-Casiano M, Saltzman RG, DaFonseca D, Caceres LV, Ramdas KN, Mendizabal A, Heldman AW, Mitrani RD, Hare JM. Florea V, et al. Among authors: difede dl. Circ Res. 2017 Nov 10;121(11):1279-1290. doi: 10.1161/CIRCRESAHA.117.311827. Epub 2017 Sep 18. Circ Res. 2017. PMID: 28923793 Free PMC article. Clinical Trial.
Study design and rationale for ELPIS: A phase I/IIb randomized pilot study of allogeneic human mesenchymal stem cell injection in patients with hypoplastic left heart syndrome.
Kaushal S, Wehman B, Pietris N, Naughton C, Bentzen SM, Bigham G, Mishra R, Sharma S, Vricella L, Everett AD, Deatrick KB, Huang S, Mehta H, Ravekes WA, Hibino N, Difede DL, Khan A, Hare JM. Kaushal S, et al. Among authors: difede dl. Am Heart J. 2017 Oct;192:48-56. doi: 10.1016/j.ahj.2017.06.009. Epub 2017 Jun 27. Am Heart J. 2017. PMID: 28938963 Clinical Trial.
25 results