Treatment of Crohn's‐Related Rectovaginal Fistula With Allogeneic Expanded‐Adipose Derived Stem Cells: A Phase I–IIa Clinical Trial
This clinical trial was to determine the safety and feasibility of expanded allogeneic adipose‐derived stem cells to treat Crohn’s‐related rectovaginal fistula (CRRVF). Sixty percent of the nonexcluded patients achieved a complete healing. This is a safe and feasible therapy for treating CRRVF, and...
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| Veröffentlicht in: | Stem cells translational medicine 2016-11, Vol.5 (11), p.1441-1446 |
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| creator | García-Arranz, Mariano Herreros, Maria Dolores González-Gómez, Carolina de la Quintana, Paloma Guadalajara, Héctor Georgiev-Hristov, Tihomir Trébol, Jacobo Garcia-Olmo, Damián |
| description | This clinical trial was to determine the safety and feasibility of expanded allogeneic adipose‐derived stem cells to treat Crohn’s‐related rectovaginal fistula (CRRVF). Sixty percent of the nonexcluded patients achieved a complete healing. This is a safe and feasible therapy for treating CRRVF, and the healing success rate appears promising.
Acknowledgements
The aim of this clinical trial was to determine the safety and feasibility of expanded allogeneic adipose‐derived stem cells to treat Crohn’s‐related rectovaginal fistula (CRRVF). We designed a phase I–II clinical trial (https://ClinicalTrials.gov, NCT00999115) to treat 10 patients with CRRVF. Patients receiving biological therapy during follow‐up were excluded. Curettage was performed, and a vaginal or rectal flap was added if the surgeon considered it necessary. The therapeutic protocol included intralesional injection of 20 million stem cells in the vaginal walls (submucosal area) and fistula tract. Healing was evaluated 12 weeks later. If the fistula had not healed, a second dose of 40 million stem cells was administered. Patient follow‐up was 52 weeks from last cell injection. Healing was defined as re‐epithelialization of both vaginal and rectal sides and absence of vaginal drainage. Cytokines and immunological blood tests were monitored. Serious adverse events or rejection issues were not observed. Five patients were excluded because biologic drugs were required to treat a Crohn's disease flare‐up during follow‐up. Cytokine profiles and immunotoxicity assays showed no statistically significant alterations. Sixty percent of the nonexcluded patients achieved a complete healing. Expanded allogeneic adipose‐derived stem‐cell injection is a safe and feasible therapy for treating CRRVF, and the healing success rate seems promising (60%). The results of this trial encourage further exploration into this therapy.
This may be the first publication in which allogeneic stem cells to treat rectovaginal fistula in Crohn´s disease seem to be a feasible and safe treatment. Additional studies are necessary to confirm the efficacy profile of the allogeneic stem cells strategy in a controlled design. |
| doi_str_mv | 10.5966/sctm.2015-0356 |
| format | Article |
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Acknowledgements
The aim of this clinical trial was to determine the safety and feasibility of expanded allogeneic adipose‐derived stem cells to treat Crohn’s‐related rectovaginal fistula (CRRVF). We designed a phase I–II clinical trial (https://ClinicalTrials.gov, NCT00999115) to treat 10 patients with CRRVF. Patients receiving biological therapy during follow‐up were excluded. Curettage was performed, and a vaginal or rectal flap was added if the surgeon considered it necessary. The therapeutic protocol included intralesional injection of 20 million stem cells in the vaginal walls (submucosal area) and fistula tract. Healing was evaluated 12 weeks later. If the fistula had not healed, a second dose of 40 million stem cells was administered. Patient follow‐up was 52 weeks from last cell injection. Healing was defined as re‐epithelialization of both vaginal and rectal sides and absence of vaginal drainage. Cytokines and immunological blood tests were monitored. Serious adverse events or rejection issues were not observed. Five patients were excluded because biologic drugs were required to treat a Crohn's disease flare‐up during follow‐up. Cytokine profiles and immunotoxicity assays showed no statistically significant alterations. Sixty percent of the nonexcluded patients achieved a complete healing. Expanded allogeneic adipose‐derived stem‐cell injection is a safe and feasible therapy for treating CRRVF, and the healing success rate seems promising (60%). The results of this trial encourage further exploration into this therapy.
This may be the first publication in which allogeneic stem cells to treat rectovaginal fistula in Crohn´s disease seem to be a feasible and safe treatment. Additional studies are necessary to confirm the efficacy profile of the allogeneic stem cells strategy in a controlled design.</description><identifier>ISSN: 2157-6564</identifier><identifier>EISSN: 2157-6580</identifier><identifier>DOI: 10.5966/sctm.2015-0356</identifier><identifier>PMID: 27412883</identifier><language>eng</language><publisher>Durham, NC, USA: AlphaMed Press</publisher><subject>Administrative support ; Allogeneic stem cells ; Cell therapy ; Clinical trials ; Crohn's disease ; Cytokines ; Data analysis ; Fecal incontinence ; Fistula ; Fistulae ; Human Clinical ; Mesenchymal stem cells ; Patients ; Rectovaginal fistula ; Stem cells ; Studies ; Surgery ; Tumor necrosis factor-TNF</subject><ispartof>Stem cells translational medicine, 2016-11, Vol.5 (11), p.1441-1446</ispartof><rights>2016 AlphaMed Press</rights><rights>AlphaMed Press.</rights><rights>2016. This work is published under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>AlphaMed Press 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4701-dbdb8bba81c94b521479baf18f996e94ef8a2d4f777933e3a70061418ff11a053</citedby><cites>FETCH-LOGICAL-c4701-dbdb8bba81c94b521479baf18f996e94ef8a2d4f777933e3a70061418ff11a053</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070505/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070505/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,864,885,1416,11561,27923,27924,45573,45574,46051,46475,53790,53792</link.rule.ids><linktorsrc>$$Uhttps://onlinelibrary.wiley.com/doi/abs/10.5966%2Fsctm.2015-0356$$EView_record_in_Wiley-Blackwell$$FView_record_in_$$GWiley-Blackwell</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27412883$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>García-Arranz, Mariano</creatorcontrib><creatorcontrib>Herreros, Maria Dolores</creatorcontrib><creatorcontrib>González-Gómez, Carolina</creatorcontrib><creatorcontrib>de la Quintana, Paloma</creatorcontrib><creatorcontrib>Guadalajara, Héctor</creatorcontrib><creatorcontrib>Georgiev-Hristov, Tihomir</creatorcontrib><creatorcontrib>Trébol, Jacobo</creatorcontrib><creatorcontrib>Garcia-Olmo, Damián</creatorcontrib><title>Treatment of Crohn's‐Related Rectovaginal Fistula With Allogeneic Expanded‐Adipose Derived Stem Cells: A Phase I–IIa Clinical Trial</title><title>Stem cells translational medicine</title><addtitle>Stem Cells Transl Med</addtitle><description>This clinical trial was to determine the safety and feasibility of expanded allogeneic adipose‐derived stem cells to treat Crohn’s‐related rectovaginal fistula (CRRVF). Sixty percent of the nonexcluded patients achieved a complete healing. This is a safe and feasible therapy for treating CRRVF, and the healing success rate appears promising.
Acknowledgements
The aim of this clinical trial was to determine the safety and feasibility of expanded allogeneic adipose‐derived stem cells to treat Crohn’s‐related rectovaginal fistula (CRRVF). We designed a phase I–II clinical trial (https://ClinicalTrials.gov, NCT00999115) to treat 10 patients with CRRVF. Patients receiving biological therapy during follow‐up were excluded. Curettage was performed, and a vaginal or rectal flap was added if the surgeon considered it necessary. The therapeutic protocol included intralesional injection of 20 million stem cells in the vaginal walls (submucosal area) and fistula tract. Healing was evaluated 12 weeks later. If the fistula had not healed, a second dose of 40 million stem cells was administered. Patient follow‐up was 52 weeks from last cell injection. Healing was defined as re‐epithelialization of both vaginal and rectal sides and absence of vaginal drainage. Cytokines and immunological blood tests were monitored. Serious adverse events or rejection issues were not observed. Five patients were excluded because biologic drugs were required to treat a Crohn's disease flare‐up during follow‐up. Cytokine profiles and immunotoxicity assays showed no statistically significant alterations. Sixty percent of the nonexcluded patients achieved a complete healing. Expanded allogeneic adipose‐derived stem‐cell injection is a safe and feasible therapy for treating CRRVF, and the healing success rate seems promising (60%). The results of this trial encourage further exploration into this therapy.
This may be the first publication in which allogeneic stem cells to treat rectovaginal fistula in Crohn´s disease seem to be a feasible and safe treatment. Additional studies are necessary to confirm the efficacy profile of the allogeneic stem cells strategy in a controlled design.</description><subject>Administrative support</subject><subject>Allogeneic stem cells</subject><subject>Cell therapy</subject><subject>Clinical trials</subject><subject>Crohn's disease</subject><subject>Cytokines</subject><subject>Data analysis</subject><subject>Fecal incontinence</subject><subject>Fistula</subject><subject>Fistulae</subject><subject>Human Clinical</subject><subject>Mesenchymal stem cells</subject><subject>Patients</subject><subject>Rectovaginal fistula</subject><subject>Stem cells</subject><subject>Studies</subject><subject>Surgery</subject><subject>Tumor necrosis factor-TNF</subject><issn>2157-6564</issn><issn>2157-6580</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqFUU1v0zAYjhCITWVXjsgSB7ik2I7txCAhVWGDSpNAWxFHy0netJ6cuNhJYbdduSHxD_dLcOiogAu-2Nbz8frxkySPCZ5zKcSLUA_dnGLCU5xxcS85poTnqeAFvn84C3aUnIRwheMSUkiKHyZHNGeEFkV2nHxbedBDB_2AXItK7zb9s3B78_0CrB6gQRdQD26n16bXFp2ZMIxWo09m2KCFtW4NPZganX7d6r6BJuoWjdm6AOgNeLOL-ssBOlSCteElWqAPGx2x5e3Nj-VSo9Ka3tTRd-WNto-SB622AU7u9lny8ex0Vb5Lz9-_XZaL87RmOSZpUzVVUVW6ILVkFaeE5bLSLSlaKQVIBm2hacPaPM9llkGm85ibsIi3hGjMs1nyeu-7HasOmjpG99qqrTed9tfKaaP-RnqzUWu3UxznmP8yeH5n4N3nEcKgOhPqGFH34MagSEFFTjGP42fJ03-oV2708SuDolRKkjGRTaz5nlV7F4KH9vAYgtVUtJqKVlPRaio6Cp78GeFA_11rJLzaE74YC9f_sVOX5SqLN8EJIYyR7CcKA7lu</recordid><startdate>201611</startdate><enddate>201611</enddate><creator>García-Arranz, Mariano</creator><creator>Herreros, Maria Dolores</creator><creator>González-Gómez, Carolina</creator><creator>de la Quintana, Paloma</creator><creator>Guadalajara, Héctor</creator><creator>Georgiev-Hristov, Tihomir</creator><creator>Trébol, Jacobo</creator><creator>Garcia-Olmo, Damián</creator><general>AlphaMed Press</general><general>Oxford University Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M7P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201611</creationdate><title>Treatment of Crohn's‐Related Rectovaginal Fistula With Allogeneic Expanded‐Adipose Derived Stem Cells: A Phase I–IIa Clinical Trial</title><author>García-Arranz, Mariano ; Herreros, Maria Dolores ; González-Gómez, Carolina ; de la Quintana, Paloma ; Guadalajara, Héctor ; Georgiev-Hristov, Tihomir ; Trébol, Jacobo ; Garcia-Olmo, Damián</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4701-dbdb8bba81c94b521479baf18f996e94ef8a2d4f777933e3a70061418ff11a053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Administrative support</topic><topic>Allogeneic stem cells</topic><topic>Cell therapy</topic><topic>Clinical trials</topic><topic>Crohn's disease</topic><topic>Cytokines</topic><topic>Data analysis</topic><topic>Fecal incontinence</topic><topic>Fistula</topic><topic>Fistulae</topic><topic>Human Clinical</topic><topic>Mesenchymal stem cells</topic><topic>Patients</topic><topic>Rectovaginal fistula</topic><topic>Stem cells</topic><topic>Studies</topic><topic>Surgery</topic><topic>Tumor necrosis factor-TNF</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>García-Arranz, Mariano</creatorcontrib><creatorcontrib>Herreros, Maria Dolores</creatorcontrib><creatorcontrib>González-Gómez, Carolina</creatorcontrib><creatorcontrib>de la Quintana, Paloma</creatorcontrib><creatorcontrib>Guadalajara, Héctor</creatorcontrib><creatorcontrib>Georgiev-Hristov, Tihomir</creatorcontrib><creatorcontrib>Trébol, Jacobo</creatorcontrib><creatorcontrib>Garcia-Olmo, Damián</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Biological Science Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Stem cells translational medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>García-Arranz, Mariano</au><au>Herreros, Maria Dolores</au><au>González-Gómez, Carolina</au><au>de la Quintana, Paloma</au><au>Guadalajara, Héctor</au><au>Georgiev-Hristov, Tihomir</au><au>Trébol, Jacobo</au><au>Garcia-Olmo, Damián</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment of Crohn's‐Related Rectovaginal Fistula With Allogeneic Expanded‐Adipose Derived Stem Cells: A Phase I–IIa Clinical Trial</atitle><jtitle>Stem cells translational medicine</jtitle><addtitle>Stem Cells Transl Med</addtitle><date>2016-11</date><risdate>2016</risdate><volume>5</volume><issue>11</issue><spage>1441</spage><epage>1446</epage><pages>1441-1446</pages><issn>2157-6564</issn><eissn>2157-6580</eissn><abstract>This clinical trial was to determine the safety and feasibility of expanded allogeneic adipose‐derived stem cells to treat Crohn’s‐related rectovaginal fistula (CRRVF). Sixty percent of the nonexcluded patients achieved a complete healing. This is a safe and feasible therapy for treating CRRVF, and the healing success rate appears promising.
Acknowledgements
The aim of this clinical trial was to determine the safety and feasibility of expanded allogeneic adipose‐derived stem cells to treat Crohn’s‐related rectovaginal fistula (CRRVF). We designed a phase I–II clinical trial (https://ClinicalTrials.gov, NCT00999115) to treat 10 patients with CRRVF. Patients receiving biological therapy during follow‐up were excluded. Curettage was performed, and a vaginal or rectal flap was added if the surgeon considered it necessary. The therapeutic protocol included intralesional injection of 20 million stem cells in the vaginal walls (submucosal area) and fistula tract. Healing was evaluated 12 weeks later. If the fistula had not healed, a second dose of 40 million stem cells was administered. Patient follow‐up was 52 weeks from last cell injection. Healing was defined as re‐epithelialization of both vaginal and rectal sides and absence of vaginal drainage. Cytokines and immunological blood tests were monitored. Serious adverse events or rejection issues were not observed. Five patients were excluded because biologic drugs were required to treat a Crohn's disease flare‐up during follow‐up. Cytokine profiles and immunotoxicity assays showed no statistically significant alterations. Sixty percent of the nonexcluded patients achieved a complete healing. Expanded allogeneic adipose‐derived stem‐cell injection is a safe and feasible therapy for treating CRRVF, and the healing success rate seems promising (60%). The results of this trial encourage further exploration into this therapy.
This may be the first publication in which allogeneic stem cells to treat rectovaginal fistula in Crohn´s disease seem to be a feasible and safe treatment. Additional studies are necessary to confirm the efficacy profile of the allogeneic stem cells strategy in a controlled design.</abstract><cop>Durham, NC, USA</cop><pub>AlphaMed Press</pub><pmid>27412883</pmid><doi>10.5966/sctm.2015-0356</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Administrative support Allogeneic stem cells Cell therapy Clinical trials Crohn's disease Cytokines Data analysis Fecal incontinence Fistula Fistulae Human Clinical Mesenchymal stem cells Patients Rectovaginal fistula Stem cells Studies Surgery Tumor necrosis factor-TNF |
| title | Treatment of Crohn's‐Related Rectovaginal Fistula With Allogeneic Expanded‐Adipose Derived Stem Cells: A Phase I–IIa Clinical Trial |
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