Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial
Preclinical studies have established that implantation of bone marrow-mononuclear cells, including endothelial progenitor cells, into ischaemic limbs increases collateral vessel formation. We investigated efficacy and safety of autologous implantation of bone marrow-mononuclear cells in patients wit...
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| Veröffentlicht in: | The Lancet (British edition) 2002-08, Vol.360 (9331), p.427-435 |
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| creator | Tateishi-Yuyama, Eriko Matsubara, Hiroaki Murohara, Toyoaki Ikeda, Uichi Shintani, Satoshi Masaki, Hiroya Amano, Katsuya Kishimoto, Yuji Yoshimoto, Kohji Akashi, Hidetoshi Shimada, Kazuyuki Iwasaka, Toshiji Imaizumi, Tsutomu |
| description | Preclinical studies have established that implantation of bone marrow-mononuclear cells, including endothelial progenitor cells, into ischaemic limbs increases collateral vessel formation. We investigated efficacy and safety of autologous implantation of bone marrow-mononuclear cells in patients with ischaemic limbs because of peripheral arterial disease.
We first did a pilot study, in which 25 patients (group A) with unilateral ischaemia of the leg were injected with bone marrow-mononuclear cells into the gastrocnemius of the ischaemic limb and with saline into the less ischaemic limb. We then recruited 22 patients (group B) with bilateral leg ischaemia, who were randomly injected with bone marrowmononuclear cells in one leg and peripheral blood-mononuclear cells in the other as a control. Primary outcomes were safety and feasibility of treatment, based on ankle-brachial index (ABI) and rest pain, and analysis was per protocol.
Two patients were excluded from group B after randomisation. At 4 weeks in group B patients, ABI was significantly improved in legs injected with bone marrowmononuclear cells compared with those injected with peripheral blood-mononuclear cells (difference 0·09 [95% CI 0·06–0·11]; p |
| doi_str_mv | 10.1016/S0140-6736(02)09670-8 |
| format | Article |
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We first did a pilot study, in which 25 patients (group A) with unilateral ischaemia of the leg were injected with bone marrow-mononuclear cells into the gastrocnemius of the ischaemic limb and with saline into the less ischaemic limb. We then recruited 22 patients (group B) with bilateral leg ischaemia, who were randomly injected with bone marrowmononuclear cells in one leg and peripheral blood-mononuclear cells in the other as a control. Primary outcomes were safety and feasibility of treatment, based on ankle-brachial index (ABI) and rest pain, and analysis was per protocol.
Two patients were excluded from group B after randomisation. At 4 weeks in group B patients, ABI was significantly improved in legs injected with bone marrowmononuclear cells compared with those injected with peripheral blood-mononuclear cells (difference 0·09 [95% CI 0·06–0·11]; p<0·0001). Similar improvements were seen for transcutaneous oxygen pressure (13 [9–17]; p<0·0001), rest pain (-0·85 [-1·6 to -0·12]; p=0·025), and pain-free walking time (1·2 [0·7–1·7]; p=0·0001). These improvements were sustained at 24 weeks. Similar improvements were seen in group A patients. Two patients in group A died after myocardial infarction unrelated to treatment.
Autologous implantation of bone marrowmononuclear cells could be safe and effective for achievement of therapeutic angiogenesis, because of the natural ability of marrow cells to supply endothelial progenitor cells and to secrete various angiogenic factors or cytokines.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(02)09670-8</identifier><identifier>PMID: 12241713</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Aged ; Anesthesia ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Angiogenesis ; Angiogenesis Inducing Agents - analysis ; Ankle ; Applied cell therapy and gene therapy ; Autografts ; Biological and medical sciences ; Blood and lymphatic vessels ; Blood vessels ; Bone marrow ; Bone Marrow Transplantation ; Cardiology. Vascular system ; Cells (biology) ; Cytokines ; Diabetes ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Evidence-based medicine ; Extremities - blood supply ; Feasibility Studies ; Female ; Foot - blood supply ; Growth factors ; Humans ; Immunohistochemistry ; Implantation ; Injection ; Ischemia ; Ischemia - therapy ; Leg ; Leukocytes (mononuclear) ; Leukocytes, Mononuclear - transplantation ; Limbs ; Male ; Medical research ; Medical sciences ; Myocardial infarction ; Neovascularization, Physiologic - physiology ; Pain ; Patients ; Peripheral blood mononuclear cells ; Pilot Projects ; Progenitor cells ; Randomization ; Safety ; Stem cells ; Transfusions. Complications. Transfusion reactions. Cell and gene therapy ; Transplantation ; Transplantation, Autologous ; Transplants & implants ; Treatment Outcome ; Walking</subject><ispartof>The Lancet (British edition), 2002-08, Vol.360 (9331), p.427-435</ispartof><rights>2002 Elsevier Ltd</rights><rights>2002 INIST-CNRS</rights><rights>Copyright Lancet Ltd. Aug 10, 2002</rights><rights>Copyright Elsevier Limited Aug 10, 2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c498t-fdeecb7204a18c2257e8be1b6557cca2d43833f95c7b8e90dcee9b4a1b08fb7e3</citedby><cites>FETCH-LOGICAL-c498t-fdeecb7204a18c2257e8be1b6557cca2d43833f95c7b8e90dcee9b4a1b08fb7e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2068362564?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13818751$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12241713$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tateishi-Yuyama, Eriko</creatorcontrib><creatorcontrib>Matsubara, Hiroaki</creatorcontrib><creatorcontrib>Murohara, Toyoaki</creatorcontrib><creatorcontrib>Ikeda, Uichi</creatorcontrib><creatorcontrib>Shintani, Satoshi</creatorcontrib><creatorcontrib>Masaki, Hiroya</creatorcontrib><creatorcontrib>Amano, Katsuya</creatorcontrib><creatorcontrib>Kishimoto, Yuji</creatorcontrib><creatorcontrib>Yoshimoto, Kohji</creatorcontrib><creatorcontrib>Akashi, Hidetoshi</creatorcontrib><creatorcontrib>Shimada, Kazuyuki</creatorcontrib><creatorcontrib>Iwasaka, Toshiji</creatorcontrib><creatorcontrib>Imaizumi, Tsutomu</creatorcontrib><creatorcontrib>for the Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators</creatorcontrib><creatorcontrib>Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators</creatorcontrib><title>Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Preclinical studies have established that implantation of bone marrow-mononuclear cells, including endothelial progenitor cells, into ischaemic limbs increases collateral vessel formation. We investigated efficacy and safety of autologous implantation of bone marrow-mononuclear cells in patients with ischaemic limbs because of peripheral arterial disease.
We first did a pilot study, in which 25 patients (group A) with unilateral ischaemia of the leg were injected with bone marrow-mononuclear cells into the gastrocnemius of the ischaemic limb and with saline into the less ischaemic limb. We then recruited 22 patients (group B) with bilateral leg ischaemia, who were randomly injected with bone marrowmononuclear cells in one leg and peripheral blood-mononuclear cells in the other as a control. Primary outcomes were safety and feasibility of treatment, based on ankle-brachial index (ABI) and rest pain, and analysis was per protocol.
Two patients were excluded from group B after randomisation. At 4 weeks in group B patients, ABI was significantly improved in legs injected with bone marrowmononuclear cells compared with those injected with peripheral blood-mononuclear cells (difference 0·09 [95% CI 0·06–0·11]; p<0·0001). Similar improvements were seen for transcutaneous oxygen pressure (13 [9–17]; p<0·0001), rest pain (-0·85 [-1·6 to -0·12]; p=0·025), and pain-free walking time (1·2 [0·7–1·7]; p=0·0001). These improvements were sustained at 24 weeks. Similar improvements were seen in group A patients. Two patients in group A died after myocardial infarction unrelated to treatment.
Autologous implantation of bone marrowmononuclear cells could be safe and effective for achievement of therapeutic angiogenesis, because of the natural ability of marrow cells to supply endothelial progenitor cells and to secrete various angiogenic factors or cytokines.</description><subject>Aged</subject><subject>Anesthesia</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Angiogenesis</subject><subject>Angiogenesis Inducing Agents - analysis</subject><subject>Ankle</subject><subject>Applied cell therapy and gene therapy</subject><subject>Autografts</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Blood vessels</subject><subject>Bone marrow</subject><subject>Bone Marrow Transplantation</subject><subject>Cardiology. Vascular system</subject><subject>Cells (biology)</subject><subject>Cytokines</subject><subject>Diabetes</subject><subject>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</subject><subject>Evidence-based medicine</subject><subject>Extremities - blood supply</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Foot - blood supply</subject><subject>Growth factors</subject><subject>Humans</subject><subject>Immunohistochemistry</subject><subject>Implantation</subject><subject>Injection</subject><subject>Ischemia</subject><subject>Ischemia - therapy</subject><subject>Leg</subject><subject>Leukocytes (mononuclear)</subject><subject>Leukocytes, Mononuclear - transplantation</subject><subject>Limbs</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Myocardial infarction</subject><subject>Neovascularization, Physiologic - physiology</subject><subject>Pain</subject><subject>Patients</subject><subject>Peripheral blood mononuclear cells</subject><subject>Pilot Projects</subject><subject>Progenitor cells</subject><subject>Randomization</subject><subject>Safety</subject><subject>Stem cells</subject><subject>Transfusions. Complications. Transfusion reactions. Cell and gene therapy</subject><subject>Transplantation</subject><subject>Transplantation, Autologous</subject><subject>Transplants & implants</subject><subject>Treatment Outcome</subject><subject>Walking</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkV1rFDEUhoModlv9CUpQKnoxmmQmk4w3IsUvKHhhBe9Ckjmzm5JNpknG0h_jfzXbXSwI4lVCeN7Dm_Mg9ISS15TQ_s03QjvS9KLtXxL2igy9II28h1a0E13DO_HjPlr9QY7Qcc6XhJCuJ_whOqKMdVTQdoV-XWwg6RmW4izWYe3iGgJkl_EUE551cRBKxteubLB3W4NdthsNW6exucF6KdHHdVwyLkmHPHsdSs3EgOOETQzQbHVK8Rpb8D6_xRrPzseCc1nGGg9jfanBMW5dhhHbGEqK3tdrSU77R-jBpH2Gx4fzBH3_-OHi7HNz_vXTl7P3543tBlmaaQSwRjDSaSotY1yANEBNz7mwVrOxa2XbTgO3wkgYyGgBBlNhQ-RkBLQn6MV-7pzi1QK5qNpnV1kHqJ9TglHKOBEVfP4XeBmXFGo3xUgv257xvqvUs39RdBgIFZzJCvE9ZFPMOcGk5uTqtm4UJWqnWN0qVjt_ijB1q1jtck8PwxezhfEudXBagdMDoLPVfqr7tS7fca2kUnBauXd7DupmfzpIKttq28LoEtiixuj-U-U32WnGXg</recordid><startdate>20020810</startdate><enddate>20020810</enddate><creator>Tateishi-Yuyama, Eriko</creator><creator>Matsubara, Hiroaki</creator><creator>Murohara, Toyoaki</creator><creator>Ikeda, Uichi</creator><creator>Shintani, Satoshi</creator><creator>Masaki, Hiroya</creator><creator>Amano, Katsuya</creator><creator>Kishimoto, Yuji</creator><creator>Yoshimoto, Kohji</creator><creator>Akashi, Hidetoshi</creator><creator>Shimada, Kazuyuki</creator><creator>Iwasaka, Toshiji</creator><creator>Imaizumi, Tsutomu</creator><general>Elsevier Ltd</general><general>Lancet</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TT</scope><scope>0TZ</scope><scope>0U~</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88A</scope><scope>88C</scope><scope>88E</scope><scope>88G</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>KB~</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>20020810</creationdate><title>Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial</title><author>Tateishi-Yuyama, Eriko ; Matsubara, Hiroaki ; Murohara, Toyoaki ; Ikeda, Uichi ; Shintani, Satoshi ; Masaki, Hiroya ; Amano, Katsuya ; Kishimoto, Yuji ; Yoshimoto, Kohji ; Akashi, Hidetoshi ; Shimada, Kazuyuki ; Iwasaka, Toshiji ; Imaizumi, Tsutomu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c498t-fdeecb7204a18c2257e8be1b6557cca2d43833f95c7b8e90dcee9b4a1b08fb7e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Aged</topic><topic>Anesthesia</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Angiogenesis</topic><topic>Angiogenesis Inducing Agents - analysis</topic><topic>Ankle</topic><topic>Applied cell therapy and gene therapy</topic><topic>Autografts</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Blood vessels</topic><topic>Bone marrow</topic><topic>Bone Marrow Transplantation</topic><topic>Cardiology. Vascular system</topic><topic>Cells (biology)</topic><topic>Cytokines</topic><topic>Diabetes</topic><topic>Diseases of the peripheral vessels. Diseases of the vena cava. 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Angiogenesis using Cell Transplantation (TACT) Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2002-08-10</date><risdate>2002</risdate><volume>360</volume><issue>9331</issue><spage>427</spage><epage>435</epage><pages>427-435</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Preclinical studies have established that implantation of bone marrow-mononuclear cells, including endothelial progenitor cells, into ischaemic limbs increases collateral vessel formation. We investigated efficacy and safety of autologous implantation of bone marrow-mononuclear cells in patients with ischaemic limbs because of peripheral arterial disease.
We first did a pilot study, in which 25 patients (group A) with unilateral ischaemia of the leg were injected with bone marrow-mononuclear cells into the gastrocnemius of the ischaemic limb and with saline into the less ischaemic limb. We then recruited 22 patients (group B) with bilateral leg ischaemia, who were randomly injected with bone marrowmononuclear cells in one leg and peripheral blood-mononuclear cells in the other as a control. Primary outcomes were safety and feasibility of treatment, based on ankle-brachial index (ABI) and rest pain, and analysis was per protocol.
Two patients were excluded from group B after randomisation. At 4 weeks in group B patients, ABI was significantly improved in legs injected with bone marrowmononuclear cells compared with those injected with peripheral blood-mononuclear cells (difference 0·09 [95% CI 0·06–0·11]; p<0·0001). Similar improvements were seen for transcutaneous oxygen pressure (13 [9–17]; p<0·0001), rest pain (-0·85 [-1·6 to -0·12]; p=0·025), and pain-free walking time (1·2 [0·7–1·7]; p=0·0001). These improvements were sustained at 24 weeks. Similar improvements were seen in group A patients. Two patients in group A died after myocardial infarction unrelated to treatment.
Autologous implantation of bone marrowmononuclear cells could be safe and effective for achievement of therapeutic angiogenesis, because of the natural ability of marrow cells to supply endothelial progenitor cells and to secrete various angiogenic factors or cytokines.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><pmid>12241713</pmid><doi>10.1016/S0140-6736(02)09670-8</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2002-08, Vol.360 (9331), p.427-435 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_72112507 |
| source | MEDLINE; Elsevier ScienceDirect Journals; Business Source Complete; ProQuest Central UK/Ireland |
| subjects | Aged Anesthesia Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Angiogenesis Angiogenesis Inducing Agents - analysis Ankle Applied cell therapy and gene therapy Autografts Biological and medical sciences Blood and lymphatic vessels Blood vessels Bone marrow Bone Marrow Transplantation Cardiology. Vascular system Cells (biology) Cytokines Diabetes Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous Evidence-based medicine Extremities - blood supply Feasibility Studies Female Foot - blood supply Growth factors Humans Immunohistochemistry Implantation Injection Ischemia Ischemia - therapy Leg Leukocytes (mononuclear) Leukocytes, Mononuclear - transplantation Limbs Male Medical research Medical sciences Myocardial infarction Neovascularization, Physiologic - physiology Pain Patients Peripheral blood mononuclear cells Pilot Projects Progenitor cells Randomization Safety Stem cells Transfusions. Complications. Transfusion reactions. Cell and gene therapy Transplantation Transplantation, Autologous Transplants & implants Treatment Outcome Walking |
| title | Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-20T13%3A01%3A50IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Therapeutic%20angiogenesis%20for%20patients%20with%20limb%20ischaemia%20by%20autologous%20transplantation%20of%20bone-marrow%20cells:%20a%20pilot%20study%20and%20a%20randomised%20controlled%20trial&rft.jtitle=The%20Lancet%20(British%20edition)&rft.au=Tateishi-Yuyama,%20Eriko&rft.aucorp=for%20the%20Therapeutic%20Angiogenesis%20using%20Cell%20Transplantation%20(TACT)%20Study%20Investigators&rft.date=2002-08-10&rft.volume=360&rft.issue=9331&rft.spage=427&rft.epage=435&rft.pages=427-435&rft.issn=0140-6736&rft.eissn=1474-547X&rft.coden=LANCAO&rft_id=info:doi/10.1016/S0140-6736(02)09670-8&rft_dat=%3Cproquest_cross%3E148940761%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=199017528&rft_id=info:pmid/12241713&rft_els_id=S0140673602096708&rfr_iscdi=true |