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Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of ex vivo amplified graft, without transfusion.
To check that injection of autologous peripheral blood stem cell CD34(+) "amplified ex vivo in the presence of SCF, G-CSF and TPO in HP01 Maco pharma medium culture. ": Allows to obtain a hematopoietic reconstitution:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | autologous peripheral blood stem cell transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous peripheral blood stem cell transplantation, ex vivo amplified | Procedure | autologous peripheral blood stem cell transplantation, ex vivo amplified |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion. | at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Toxicity of the injection of the amplified graft ; | just after the injection of the amplified graft | |
| Quantitative immunological Reconstitution | at day 30, 100, 180, 270, 360 after the injection and then every 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel MILPIED, MS, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Haut-Leveque | Pessac | 33604 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1710148 | Background | Bernstein ID, Andrews RG, Zsebo KM. Recombinant human stem cell factor enhances the formation of colonies by CD34+ and CD34+lin- cells, and the generation of colony-forming cell progeny from CD34+lin- cells cultured with interleukin-3, granulocyte colony-stimulating factor, or granulocyte-macrophage colony-stimulating factor. Blood. 1991 Jun 1;77(11):2316-21. | |
| 1714328 |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Stability of the hematopoiesis in the long term | at 1, 3, 6, 9 and 12 months after the graft |
| Absence of cytogenetics abnormalities not related to the multiple myeloma in the long term. | at 1, 3, 6, 9 and 12 months after the injection |
| Bodine DM, Crosier PS, Clark SC. Effects of hematopoietic growth factors on the survival of primitive stem cells in liquid suspension culture. Blood. 1991 Aug 15;78(4):914-20. |
| 8104070 | Background | Boiron JM, Marit G, Faberes C, Cony-Makhoul P, Foures C, Ferrer AM, Cristol G, Sarrat A, Girault D, Reiffers J. Collection of peripheral blood stem cells in multiple myeloma following single high-dose cyclophosphamide with and without recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF). Bone Marrow Transplant. 1993 Jul;12(1):49-55. |
| 1697607 | Background | Brandt J, Srour EF, van Besien K, Briddell RA, Hoffman R. Cytokine-dependent long-term culture of highly enriched precursors of hematopoietic progenitor cells from human bone marrow. J Clin Invest. 1990 Sep;86(3):932-41. doi: 10.1172/JCI114795. |
| 7541111 | Background | Brugger W, Heimfeld S, Berenson RJ, Mertelsmann R, Kanz L. Reconstitution of hematopoiesis after high-dose chemotherapy by autologous progenitor cells generated ex vivo. N Engl J Med. 1995 Aug 3;333(5):283-7. doi: 10.1056/NEJM199508033330503. |
|
| 1381625 | Background | Haylock DN, To LB, Dowse TL, Juttner CA, Simmons PJ. Ex vivo expansion and maturation of peripheral blood CD34+ cells into the myeloid lineage. Blood. 1992 Sep 15;80(6):1405-12. |
| 2784460 | Background | Iscove NN, Shaw AR, Keller G. Net increase of pluripotential hematopoietic precursors in suspension culture in response to IL-1 and IL-3. J Immunol. 1989 Apr 1;142(7):2332-7. |
| 16398741 | Background | Ivanovic Z, Duchez P, Dazey B, Hermitte F, Lamrissi-Garcia I, Mazurier F, Praloran V, Reiffers J, Vezon G, Boiron JM. A clinical-scale expansion of mobilized CD 34+ hematopoietic stem and progenitor cells by use of a new serum-free medium. Transfusion. 2006 Jan;46(1):126-31. doi: 10.1111/j.1537-2995.2005.00675.x. |
| 1717075 | Background | Kobayashi M, Imamura M, Gotohda Y, Maeda S, Iwasaki H, Sakurada K, Kasai M, Hapel AJ, Miyazaki T. Synergistic effects of interleukin-1 beta and interleukin-3 on the expansion of human hematopoietic progenitor cells in liquid cultures. Blood. 1991 Oct 15;78(8):1947-53. |
| 2070044 | Background | Moore MA. Review: Stratton Lecture 1990. Clinical implications of positive and negative hematopoietic stem cell regulators. Blood. 1991 Jul 1;78(1):1-19. No abstract available. |
| 9815881 | Background | Moore MA. Hematopoietic reconstruction: new approaches. Clin Cancer Res. 1995 Jan;1(1):3-9. No abstract available. |
| 1587307 | Background | Muench MO, Moore MA. Accelerated recovery of peripheral blood cell counts in mice transplanted with in vitro cytokine-expanded hematopoietic progenitors. Exp Hematol. 1992 Jun;20(5):611-8. |
| 1373685 | Background | Muench MO, Schneider JG, Moore MA. Interactions among colony-stimulating factors, IL-1 beta, IL-6, and kit-ligand in the regulation of primitive murine hematopoietic cells. Exp Hematol. 1992 Mar;20(3):339-49. |
| 10147738 | Background | Reiffers J, Marit G, Vezon G, Cony-Makhoul P, Boiron JM, Montastruc M, Rice A, Broustet A. Autologous blood stem cell grafting in hematological malignancies. Present status and future directions. Transfus Sci. 1992;13(4):399-405. doi: 10.1016/0955-3886(92)90024-B. No abstract available. |
| 7530133 | Background | Reiffers J, Faberes C, Boiron JM, Marit G, Foures C, Ferrer AM, Cony-Makhoul P, Puntous M, Bernard P, Vezon G, et al. Peripheral blood progenitor cell transplantation in 118 patients with hematological malignancies: analysis of factors affecting the rate of engraftment. J Hematother. 1994 Fall;3(3):185-91. doi: 10.1089/scd.1.1994.3.185. |
| 7522897 | Background | Rice A, Boiron JM, Barbot C, Dupouy M, Dubsoc-Marchenay N, Dumain P, Lacombe F, Reiffers J. Cytokine-mediated expansion of 5-FU resistant peripheral blood stem cells and bone marrow: self-renewal and commitment capacity. J Hematother. 1994 Summer;3(2):135-9. doi: 10.1089/scd.1.1994.3.135. |
| 8443377 | Background | Shih JP, Ogawa M. Monoclonal antibody J11d.2 recognizes cell cycle-dormant, primitive hematopoietic progenitors of mice. Blood. 1993 Mar 1;81(5):1155-60. |
| 1709369 | Background | Smith C, Gasparetto C, Collins N, Gillio A, Muench MO, O'Reilly RJ, Moore MA. Purification and partial characterization of a human hematopoietic precursor population. Blood. 1991 May 15;77(10):2122-8. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |