Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration

Background. Stromal vascular fraction (SVF) therapy has been performed over the past six years to treat 421 patients by our group in five clinical centers. Autologous SVF, which is a substance containing stem cells, was isolated from lipoaspirate, mixed with platelet-rich plasma (PRP), and administe...

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Main Authors: Karina Karina, Iis Rosliana, Imam Rosadi, Rachel Schwartz, Siti Sobariah, Irsyah Afini, Tias Widyastuti, Melinda Remelia, Komang Ardi Wahyuningsih, Jeanne A. Pawitan
Format: Article
Language:English
Published: Wiley 2020-01-01
Series:Scientifica
Online Access:http://dx.doi.org/10.1155/2020/2863624
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author Karina Karina
Iis Rosliana
Imam Rosadi
Rachel Schwartz
Siti Sobariah
Irsyah Afini
Tias Widyastuti
Melinda Remelia
Komang Ardi Wahyuningsih
Jeanne A. Pawitan
author_facet Karina Karina
Iis Rosliana
Imam Rosadi
Rachel Schwartz
Siti Sobariah
Irsyah Afini
Tias Widyastuti
Melinda Remelia
Komang Ardi Wahyuningsih
Jeanne A. Pawitan
author_sort Karina Karina
collection DOAJ
description Background. Stromal vascular fraction (SVF) therapy has been performed over the past six years to treat 421 patients by our group in five clinical centers. Autologous SVF, which is a substance containing stem cells, was isolated from lipoaspirate, mixed with platelet-rich plasma (PRP), and administered to patients with degenerative diseases, autoimmune diseases, trauma, aging, and other diseases with unknown etiology. This study aimed to determine the safety of SVF and PRP that were given through infusion, spinal, and intra-articular injection. Methods. The lipoaspirate was treated with a tissue-dissociating enzyme, and then, through centrifugation, SVF was isolated. In addition, blood was drawn from each patient, and PRP was isolated. Autologous PRP and SVF were administered to all subjects by intravenous (IV) injection. A minority group within the population received an additional spinal or intra-articular injection. The type of intervention was determined by each disease evaluation. The cell doses and adverse events for each patient were documented and analyzed. Results. Cell dose that was considered to be safe was less than 10 billion SVF cells in 250 cc of normal saline, for IV injection, and less than 1 billion SVF, for intra-articular and spinal injection. Adverse events were not severe and were treated successfully. Any observed adverse events were identified as a result of spinal or intra-articular injections and were not related to SVF or PRP. Conclusions. Our results showed that administration of high dose of SVF until 10 billion cells in a majority of 421 patients through infusion, spinal, and intra-articular injection was feasible without causing major adverse events and should be further investigated in well-designed phase I-II clinical trial to address the safety and efficacy of therapy.
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spelling doaj-art-02a1c9fa76ea4570aa91328da5993dfb2025-08-20T02:03:27ZengWileyScientifica2090-908X2020-01-01202010.1155/2020/28636242863624Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell AdministrationKarina Karina0Iis Rosliana1Imam Rosadi2Rachel Schwartz3Siti Sobariah4Irsyah Afini5Tias Widyastuti6Melinda Remelia7Komang Ardi Wahyuningsih8Jeanne A. Pawitan9Klinik Hayandra, Yayasan Hayandra Peduli, Jl. Kramat VI No. 11, Jakarta Pusat, IndonesiaHayandraLab, Yayasan Hayandra Peduli, Jl. Kramat VI No. 11, Jakarta Pusat, IndonesiaHayandraLab, Yayasan Hayandra Peduli, Jl. Kramat VI No. 11, Jakarta Pusat, IndonesiaHayandraLab, Yayasan Hayandra Peduli, Jl. Kramat VI No. 11, Jakarta Pusat, IndonesiaHayandraLab, Yayasan Hayandra Peduli, Jl. Kramat VI No. 11, Jakarta Pusat, IndonesiaHayandraLab, Yayasan Hayandra Peduli, Jl. Kramat VI No. 11, Jakarta Pusat, IndonesiaHayandraLab, Yayasan Hayandra Peduli, Jl. Kramat VI No. 11, Jakarta Pusat, IndonesiaDepartment of Basic Biomedicine, Faculty of Medicine, Universitas Kristen Indonesia, Jakarta, IndonesiaKlinik Hayandra, Yayasan Hayandra Peduli, Jl. Kramat VI No. 11, Jakarta Pusat, IndonesiaDepartment of Histology, Faculty of Medicine, Universitas Indonesia, Jl. Salemba 6, Jakarta Pusat, IndonesiaBackground. Stromal vascular fraction (SVF) therapy has been performed over the past six years to treat 421 patients by our group in five clinical centers. Autologous SVF, which is a substance containing stem cells, was isolated from lipoaspirate, mixed with platelet-rich plasma (PRP), and administered to patients with degenerative diseases, autoimmune diseases, trauma, aging, and other diseases with unknown etiology. This study aimed to determine the safety of SVF and PRP that were given through infusion, spinal, and intra-articular injection. Methods. The lipoaspirate was treated with a tissue-dissociating enzyme, and then, through centrifugation, SVF was isolated. In addition, blood was drawn from each patient, and PRP was isolated. Autologous PRP and SVF were administered to all subjects by intravenous (IV) injection. A minority group within the population received an additional spinal or intra-articular injection. The type of intervention was determined by each disease evaluation. The cell doses and adverse events for each patient were documented and analyzed. Results. Cell dose that was considered to be safe was less than 10 billion SVF cells in 250 cc of normal saline, for IV injection, and less than 1 billion SVF, for intra-articular and spinal injection. Adverse events were not severe and were treated successfully. Any observed adverse events were identified as a result of spinal or intra-articular injections and were not related to SVF or PRP. Conclusions. Our results showed that administration of high dose of SVF until 10 billion cells in a majority of 421 patients through infusion, spinal, and intra-articular injection was feasible without causing major adverse events and should be further investigated in well-designed phase I-II clinical trial to address the safety and efficacy of therapy.http://dx.doi.org/10.1155/2020/2863624
spellingShingle Karina Karina
Iis Rosliana
Imam Rosadi
Rachel Schwartz
Siti Sobariah
Irsyah Afini
Tias Widyastuti
Melinda Remelia
Komang Ardi Wahyuningsih
Jeanne A. Pawitan
Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration
Scientifica
title Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration
title_full Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration
title_fullStr Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration
title_full_unstemmed Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration
title_short Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration
title_sort safety of technique and procedure of stromal vascular fraction therapy from liposuction to cell administration
url http://dx.doi.org/10.1155/2020/2863624
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