Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease

Abstract Buerger's disease or thromboangiitis obliterans is a type of obstructive vascular diseases categorized as vasculitis and usually present in 95% of young smoker men. The main pathogenetic mechanism is interplay between immune system and inflammation. Earlier our phase II study has shown...

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Autores principales:	Pawan Kumar Gupta, Santanu Dutta, Sanjay Kala, Muralikrishna Nekkanti, Sanjay C. Desai, Subhendu S. Mahapatra, Anita Dhar, Radhakrishnan Raju, Rajkumar M., Arunanshu Behera, Shivashankar P., N.S. Raviraja, Pachaiyappan Viswanathan, Mithun Chandrashekar, Charan Thej, Prasanth K.V., Jijy Abraham, Hema Boggarapu, K. Udaykumar
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	angiogenesis ankle brachial pressure index critical limb ischemia mesenchymal stromal cells rest pain score Rutherford III‐5 or III‐6 Medicine (General) R5-920 Cytology QH573-671
Acceso en línea:	https://doaj.org/article/d9172901775d4f848f334111134a5c7c
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spelling	oai:doaj.org-article:d9172901775d4f848f334111134a5c7c2021-12-03T12:11:46ZPhase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease2157-65802157-656410.1002/sctm.21-0197https://doaj.org/article/d9172901775d4f848f334111134a5c7c2021-12-01T00:00:00Zhttps://doi.org/10.1002/sctm.21-0197https://doaj.org/toc/2157-6564https://doaj.org/toc/2157-6580Abstract Buerger's disease or thromboangiitis obliterans is a type of obstructive vascular diseases categorized as vasculitis and usually present in 95% of young smoker men. The main pathogenetic mechanism is interplay between immune system and inflammation. Earlier our phase II study has shown that Stempeucel is safe when injected at 2 million cells/kg body weight by virtue of its anti‐inflammatory, immunomodulatory, and angiogenetic properties. The present study was conducted to further assess the safety and efficacy of Stempeucel in critical limb ischemia due to Buerger's disease after obtaining approval from Indian FDA based on the data generated in the phase II study. This is an open label, multicenteric phase IV PMS study conducted across India with experienced vascular surgeons. Fifty patients of critical limb ischemia due to Buerger's disease with Rutherford III‐5 or III‐6 were included in the study and each individual received a dose of 2 million cells/kg body weight of Stempeucel in the calf muscles and around the ulcer. These patients were evaluated over 12 months from drug administration. The present study showed the continued long term efficacy over a period of 12 months follow up in these patients corroborating the result obtained in the previous phase II studies. There was significant improvement in rest pain, ankle systolic pressure, and ankle brachial pressure index with accelerated ulcer healing. In conclusion, the present study shows that the intramuscular administration of Stempeucel continues to be safe, tolerable, and effective alternative treatment in patients with Buerger's disease.Pawan Kumar GuptaSantanu DuttaSanjay KalaMuralikrishna NekkantiSanjay C. DesaiSubhendu S. MahapatraAnita DharRadhakrishnan RajuRajkumar M.Arunanshu BeheraShivashankar P.N.S. RavirajaPachaiyappan ViswanathanMithun ChandrashekarCharan ThejPrasanth K.V.Jijy AbrahamHema BoggarapuK. UdaykumarWileyarticleangiogenesisankle brachial pressure indexcritical limb ischemiamesenchymal stromal cellsrest pain scoreRutherford III‐5 or III‐6Medicine (General)R5-920CytologyQH573-671ENStem Cells Translational Medicine, Vol 10, Iss 12, Pp 1602-1613 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	angiogenesis ankle brachial pressure index critical limb ischemia mesenchymal stromal cells rest pain score Rutherford III‐5 or III‐6 Medicine (General) R5-920 Cytology QH573-671
spellingShingle	angiogenesis ankle brachial pressure index critical limb ischemia mesenchymal stromal cells rest pain score Rutherford III‐5 or III‐6 Medicine (General) R5-920 Cytology QH573-671 Pawan Kumar Gupta Santanu Dutta Sanjay Kala Muralikrishna Nekkanti Sanjay C. Desai Subhendu S. Mahapatra Anita Dhar Radhakrishnan Raju Rajkumar M. Arunanshu Behera Shivashankar P. N.S. Raviraja Pachaiyappan Viswanathan Mithun Chandrashekar Charan Thej Prasanth K.V. Jijy Abraham Hema Boggarapu K. Udaykumar Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease
description	Abstract Buerger's disease or thromboangiitis obliterans is a type of obstructive vascular diseases categorized as vasculitis and usually present in 95% of young smoker men. The main pathogenetic mechanism is interplay between immune system and inflammation. Earlier our phase II study has shown that Stempeucel is safe when injected at 2 million cells/kg body weight by virtue of its anti‐inflammatory, immunomodulatory, and angiogenetic properties. The present study was conducted to further assess the safety and efficacy of Stempeucel in critical limb ischemia due to Buerger's disease after obtaining approval from Indian FDA based on the data generated in the phase II study. This is an open label, multicenteric phase IV PMS study conducted across India with experienced vascular surgeons. Fifty patients of critical limb ischemia due to Buerger's disease with Rutherford III‐5 or III‐6 were included in the study and each individual received a dose of 2 million cells/kg body weight of Stempeucel in the calf muscles and around the ulcer. These patients were evaluated over 12 months from drug administration. The present study showed the continued long term efficacy over a period of 12 months follow up in these patients corroborating the result obtained in the previous phase II studies. There was significant improvement in rest pain, ankle systolic pressure, and ankle brachial pressure index with accelerated ulcer healing. In conclusion, the present study shows that the intramuscular administration of Stempeucel continues to be safe, tolerable, and effective alternative treatment in patients with Buerger's disease.
format	article
author	Pawan Kumar Gupta Santanu Dutta Sanjay Kala Muralikrishna Nekkanti Sanjay C. Desai Subhendu S. Mahapatra Anita Dhar Radhakrishnan Raju Rajkumar M. Arunanshu Behera Shivashankar P. N.S. Raviraja Pachaiyappan Viswanathan Mithun Chandrashekar Charan Thej Prasanth K.V. Jijy Abraham Hema Boggarapu K. Udaykumar
author_facet	Pawan Kumar Gupta Santanu Dutta Sanjay Kala Muralikrishna Nekkanti Sanjay C. Desai Subhendu S. Mahapatra Anita Dhar Radhakrishnan Raju Rajkumar M. Arunanshu Behera Shivashankar P. N.S. Raviraja Pachaiyappan Viswanathan Mithun Chandrashekar Charan Thej Prasanth K.V. Jijy Abraham Hema Boggarapu K. Udaykumar
author_sort	Pawan Kumar Gupta
title	Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease
title_short	Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease
title_full	Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease
title_fullStr	Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease
title_full_unstemmed	Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease
title_sort	phase iv postmarketing surveillance study shows continued efficacy and safety of stempeucel in patients with critical limb ischemia due to buerger's disease
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/d9172901775d4f848f334111134a5c7c
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Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease

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