Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT00765050
Status:
TERMINATED
Last Update Posted:
2014-04-07
First Post:
2008-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562746', 'term': 'Macular Dystrophy, Retinal, 2'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2008-10-01', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood', 'timeFrame': '2 months'}, {'measure': 'To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs', 'timeFrame': '12 months'}, {'measure': 'To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cellular therapy', 'CD133+'], 'conditions': ['Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF']}, 'referencesModule': {'references': [{'pmid': '1834364', 'type': 'BACKGROUND', 'citation': 'Second European Consensus Document on chronic critical leg ischemia. 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Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.'}, {'pmid': '10436164', 'type': 'BACKGROUND', 'citation': 'Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, Kearne M, Magner M, Isner JM. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999 Aug 6;85(3):221-8. doi: 10.1161/01.res.85.3.221.'}, {'pmid': '10406801', 'type': 'BACKGROUND', 'citation': 'Asahara T, Takahashi T, Masuda H, Kalka C, Chen D, Iwaguro H, Inai Y, Silver M, Isner JM. VEGF contributes to postnatal neovascularization by mobilizing bone marrow-derived endothelial progenitor cells. EMBO J. 1999 Jul 15;18(14):3964-72. doi: 10.1093/emboj/18.14.3964.'}, {'pmid': '17354105', 'type': 'BACKGROUND', 'citation': 'Canizo MC, Lozano F, Gonzalez-Porras JR, Barros M, Lopez-Holgado N, Briz E, Sanchez-Guijo FM. Peripheral endothelial progenitor cells (CD133 +) for therapeutic vasculogenesis in a patient with critical limb ischemia. One year follow-up. Cytotherapy. 2007;9(1):99-102. doi: 10.1080/14653240601034708.'}, {'pmid': '9831864', 'type': 'BACKGROUND', 'citation': 'de Wynter EA, Buck D, Hart C, Heywood R, Coutinho LH, Clayton A, Rafferty JA, Burt D, Guenechea G, Bueren JA, Gagen D, Fairbairn LJ, Lord BI, Testa NG. CD34+AC133+ cells isolated from cord blood are highly enriched in long-term culture-initiating cells, NOD/SCID-repopulating cells and dendritic cell progenitors. Stem Cells. 1998;16(6):387-96. doi: 10.1002/stem.160387.'}, {'pmid': '16926085', 'type': 'BACKGROUND', 'citation': 'Durdu S, Akar AR, Arat M, Sancak T, Eren NT, Ozyurda U. Autologous bone-marrow mononuclear cell implantation for patients with Rutherford grade II-III thromboangiitis obliterans. J Vasc Surg. 2006 Oct;44(4):732-9. doi: 10.1016/j.jvs.2006.06.023. 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Vascular trauma induces rapid but transient mobilization of VEGFR2(+)AC133(+) endothelial precursor cells. Circ Res. 2001 Feb 2;88(2):167-74. doi: 10.1161/01.res.88.2.167.'}, {'pmid': '12621502', 'type': 'BACKGROUND', 'citation': 'Gordon PR, Leimig T, Babarin-Dorner A, Houston J, Holladay M, Mueller I, Geiger T, Handgretinger R. Large-scale isolation of CD133+ progenitor cells from G-CSF mobilized peripheral blood stem cells. Bone Marrow Transplant. 2003 Jan;31(1):17-22. doi: 10.1038/sj.bmt.1703792.'}, {'pmid': '7538919', 'type': 'BACKGROUND', 'citation': 'Isner JM, Walsh K, Symes J, Pieczek A, Takeshita S, Lowry J, Rossow S, Rosenfield K, Weir L, Brogi E, et al. Arterial gene therapy for therapeutic angiogenesis in patients with peripheral artery disease. Circulation. 1995 Jun 1;91(11):2687-92. doi: 10.1161/01.cir.91.11.2687. No abstract available.'}, {'pmid': '11390421', 'type': 'BACKGROUND', 'citation': 'Jackson KA, Majka SM, Wang H, Pocius J, Hartley CJ, Majesky MW, Entman ML, Michael LH, Hirschi KK, Goodell MA. Regeneration of ischemic cardiac muscle and vascular endothelium by adult stem cells. J Clin Invest. 2001 Jun;107(11):1395-402. doi: 10.1172/JCI12150.'}, {'pmid': '17251666', 'type': 'BACKGROUND', 'citation': 'Kajiguchi M, Kondo T, Izawa H, Kobayashi M, Yamamoto K, Shintani S, Numaguchi Y, Naoe T, Takamatsu J, Komori K, Murohara T. Safety and efficacy of autologous progenitor cell transplantation for therapeutic angiogenesis in patients with critical limb ischemia. Circ J. 2007 Feb;71(2):196-201. doi: 10.1253/circj.71.196.'}, {'pmid': '10864908', 'type': 'BACKGROUND', 'citation': 'Kalka C, Masuda H, Takahashi T, Gordon R, Tepper O, Gravereaux E, Pieczek A, Iwaguro H, Hayashi SI, Isner JM, Asahara T. Vascular endothelial growth factor(165) gene transfer augments circulating endothelial progenitor cells in human subjects. Circ Res. 2000 Jun 23;86(12):1198-202. doi: 10.1161/01.res.86.12.1198.'}, {'pmid': '8759907', 'type': 'BACKGROUND', 'citation': 'Kawachi Y, Watanabe A, Uchida T, Yoshizawa K, Kurooka N, Setsu K. Acute arterial thrombosis due to platelet aggregation in a patient receiving granulocyte colony-stimulating factor. Br J Haematol. 1996 Aug;94(2):413-6. doi: 10.1046/j.1365-2141.1996.d01-1807.x.'}, {'pmid': '10725398', 'type': 'BACKGROUND', 'citation': 'Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. doi: 10.1073/pnas.97.7.3422.'}, {'pmid': '11283669', 'type': 'BACKGROUND', 'citation': 'Kocher AA, Schuster MD, Szabolcs MJ, Takuma S, Burkhoff D, Wang J, Homma S, Edwards NM, Itescu S. Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function. Nat Med. 2001 Apr;7(4):430-6. doi: 10.1038/86498.'}, {'pmid': '17308520', 'type': 'BACKGROUND', 'citation': 'Kolvenbach R, Kreissig C, Ludwig E, Cagiannos C. Stem cell use in critical limb ischemia. J Cardiovasc Surg (Torino). 2007 Feb;48(1):39-44.'}, {'pmid': '14675410', 'type': 'BACKGROUND', 'citation': 'Lang P, Bader P, Schumm M, Feuchtinger T, Einsele H, Fuhrer M, Weinstock C, Handgretinger R, Kuci S, Martin D, Niethammer D, Greil J. Transplantation of a combination of CD133+ and CD34+ selected progenitor cells from alternative donors. Br J Haematol. 2004 Jan;124(1):72-9. doi: 10.1046/j.1365-2141.2003.04747.x.'}, {'pmid': '11852257', 'type': 'BACKGROUND', 'citation': 'Luttun A, Carmeliet G, Carmeliet P. Vascular progenitors: from biology to treatment. Trends Cardiovasc Med. 2002 Feb;12(2):88-96. doi: 10.1016/s1050-1738(01)00152-9.'}, {'pmid': '12160849', 'type': 'BACKGROUND', 'citation': 'Murayama T, Tepper OM, Silver M, Ma H, Losordo DW, Isner JM, Asahara T, Kalka C. Determination of bone marrow-derived endothelial progenitor cell significance in angiogenic growth factor-induced neovascularization in vivo. Exp Hematol. 2002 Aug;30(8):967-72. doi: 10.1016/s0301-472x(02)00867-6.'}, {'pmid': '17717827', 'type': 'BACKGROUND', 'citation': 'Zhang HK, Li M, Feng H. [Autologous transplantation of peripheral blood stem cell in treatment of critical limb ischemia]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2007 Jul;36(4):360-3. doi: 10.3785/j.issn.1008-9292.2007.04.009. Chinese.'}, {'pmid': '11287958', 'type': 'BACKGROUND', 'citation': 'Orlic D, Kajstura J, Chimenti S, Jakoniuk I, Anderson SM, Li B, Pickel J, McKay R, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Bone marrow cells regenerate infarcted myocardium. Nature. 2001 Apr 5;410(6829):701-5. doi: 10.1038/35070587.'}, {'pmid': '11504914', 'type': 'BACKGROUND', 'citation': 'Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Mobilized bone marrow cells repair the infarcted heart, improving function and survival. Proc Natl Acad Sci U S A. 2001 Aug 28;98(18):10344-9. doi: 10.1073/pnas.181177898. Epub 2001 Aug 14.'}, {'pmid': '10648408', 'type': 'BACKGROUND', 'citation': 'Peichev M, Naiyer AJ, Pereira D, Zhu Z, Lane WJ, Williams M, Oz MC, Hicklin DJ, Witte L, Moore MA, Rafii S. Expression of VEGFR-2 and AC133 by circulating human CD34(+) cells identifies a population of functional endothelial precursors. 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Circulation. 2000 Sep 12;102(11):E73-86. doi: 10.1161/01.cir.102.11.e73.'}, {'pmid': '12517467', 'type': 'BACKGROUND', 'citation': 'Stamm C, Westphal B, Kleine HD, Petzsch M, Kittner C, Klinge H, Schumichen C, Nienaber CA, Freund M, Steinhoff G. Autologous bone-marrow stem-cell transplantation for myocardial regeneration. Lancet. 2003 Jan 4;361(9351):45-6. doi: 10.1016/S0140-6736(03)12110-1.'}, {'pmid': '10202935', 'type': 'BACKGROUND', 'citation': 'Takahashi T, Kalka C, Masuda H, Chen D, Silver M, Kearney M, Magner M, Isner JM, Asahara T. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med. 1999 Apr;5(4):434-8. doi: 10.1038/7434.'}, {'pmid': '12241713', 'type': 'BACKGROUND', 'citation': 'Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.'}, {'pmid': '11772882', 'type': 'BACKGROUND', 'citation': 'Toma C, Pittenger MF, Cahill KS, Byrne BJ, Kessler PD. Human mesenchymal stem cells differentiate to a cardiomyocyte phenotype in the adult murine heart. Circulation. 2002 Jan 1;105(1):93-8. doi: 10.1161/hc0102.101442.'}, {'pmid': '12517468', 'type': 'BACKGROUND', 'citation': 'Tse HF, Kwong YL, Chan JK, Lo G, Ho CL, Lau CP. Angiogenesis in ischaemic myocardium by intramyocardial autologous bone marrow mononuclear cell implantation. Lancet. 2003 Jan 4;361(9351):47-9. doi: 10.1016/S0140-6736(03)12111-3.'}, {'pmid': '8609212', 'type': 'BACKGROUND', 'citation': 'Weiss MJ, Orkin SH. In vitro differentiation of murine embryonic stem cells. New approaches to old problems. J Clin Invest. 1996 Feb 1;97(3):591-5. doi: 10.1172/JCI118454. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.aehh.org', 'label': 'Spanish association of Haematology'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.\n\nThe secondary objectives are:\n\n* To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.\n* To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs.\n* To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients', 'detailedDescription': 'A total of up to 20 diabetic patients with critic ischemia of lower limbs will be included in the study. Patients will be administered with CD133+ cells, that previously have been obtained of their peripheral blood after mobilization with G-CSF\n\nThe study is divided in three phases:\n\nPre-treatment (previous 4 weeks of CD133+ cells mobilization). Treatment (cells mobilization, CD133+ transplant, 24 hours after infusion visit, 4, 12 and 24 weeks after transplant visits) Follow-up (9 and 12 months after transplant visits)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* According to the investigator opinion, patient is able to carry out with all the clinical trial requirements\n* Patient must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. Patient must know that he/she can abandon the study at any time with no damage to his/her posterior attention\n* Age 18 to 75\n* A diagnosis of chronic critic ischemia of the lower limbs\n* Diabetes Mellitus active\n* III or IV stages (Fontaine classification): resting pain, ulcer or minor gangrene with no major amputation\n* General contraindication or local inoperability or refractory/progression after previous surgical treatment, according to the investigator criteria\n* If female reproductive potential, negative pregnancy test\n\nExclusion Criteria:\n\n* Pregnant or currently breast feeding women\n* Acute myocardial infarction within the last 3 years\n* Non re-vascular unstable angina pectoris\n* History of ischemia stroke within the last 3 years\n* Neoplasia at the time of inclusion or Chemotherapy or Radiotherapy treatment in the last 5 years\n* Chronic renal insufficiency\n* G-CSF contraindication\n* A non well controlled serious concomitant disease\n* History of serious thrombotic episodes within the past 3 years\n* Patients who have received other investigational therapy within 30 days previous to the study inclusion\n* Patients currently in other clinical trial or receiving any other investigational agent'}, 'identificationModule': {'nctId': 'NCT00765050', 'briefTitle': 'A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF', 'organization': {'class': 'OTHER', 'fullName': 'PETHEMA Foundation'}, 'officialTitle': 'A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF', 'orgStudyIdInfo': {'id': '2008-000693-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD133+ cells', 'description': 'CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.', 'interventionNames': ['Biological: CD133+ cells transplant']}], 'interventions': [{'name': 'CD133+ cells transplant', 'type': 'BIOLOGICAL', 'description': 'intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.', 'armGroupLabels': ['CD133+ cells']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Joan XIII de', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Mª Consuelo Del Cañizo, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clínico de Salamanca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PETHEMA Foundation', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'PETHEMA Foundation', 'oldOrganization': 'PETHEMA'}}}}