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  • 1
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    Online Resource
    Randomized controlled trials of autologous hematopoietic stem cell transplantation for autoimmune diseases: The evolution from myeloablative to lymphoablative transplant regimens
    Wiley ; 2006
    In:  Arthritis & Rheumatism Vol. 54, No. 12 ( 2006-12), p. 3750-3760
    Details
    In: Arthritis & Rheumatism, Wiley, Vol. 54, No. 12 ( 2006-12), p. 3750-3760
    Type of Medium: Online Resource
    ISSN: 0004-3591 , 1529-0131
    URL: Issue
    URL: Article
    DOI: 10.1002/art.v54:12
    DOI: 10.1002/art.22256
    RVK:
    XA 10000
    RVK:
    XA 30325
    Language: English
    Publisher: Wiley
    Publication Date: 2006
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  • 2
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    Novel TNF antagonists for the treatment of rheumatoid arthritis
    Informa UK Limited ; 2010
    In:  Expert Opinion on Investigational Drugs Vol. 19, No. 1 ( 2010-01), p. 105-115
    Details
    In: Expert Opinion on Investigational Drugs, Informa UK Limited, Vol. 19, No. 1 ( 2010-01), p. 105-115
    Type of Medium: Online Resource
    ISSN: 1354-3784 , 1744-7658
    URL: Article
    DOI: 10.1517/13543780903438559
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2010
    detail.hit.zdb_id: 2030114-5
    SSG: 15,3
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  • 3
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    Autologous Non-Myeloablative Hematopoietic Stem Cell Transplantation for Diffuse Scleroderma.
    American Society of Hematology ; 2005
    In:  Blood Vol. 106, No. 11 ( 2005-11-16), p. 2920-2920
    Details
    In: Blood, American Society of Hematology, Vol. 106, No. 11 ( 2005-11-16), p. 2920-2920
    Abstract: Background & Aims Scleroderma is an immune mediated vasculopathy of unknown etiology. There is no known therapy that could alter the natural course of the disease. Patients with diffuse cutaneous disease or visceral involvement has an overall 10-year survival of 35 to 68%. Autologous hematopoietic stem cell transplantation (HSCT) with myeloablative regimen has been performed, but with substantial mortality and morbidity especially pulmonary and renal toxicity. We have performed autologous HSCT utilizing non-myeloablative, but lymphoablative conditioning. Methods We conducted a phase 1 HSCT study in 9 patients with diffuse scleroderma with poor clinical features. Candidates were less than 65 years old with Rodman score of more than 14 or diffusion capacity less than 80%, interstitial lung disease, elevated ESR, renal involvement, or abnormal electrocardiogram. Patients with pulmonary hypertension (systolic pressure 〉 45 mm Hg) were excluded. Peripheral blood stem cells were mobilized with cyclophosphamide and granulocyte colony-stimulating factor. The graft was not manipulated. The conditioning regimen consisted of 200mg/kg cyclophosphamide (CY), and 7.5mg/kg rabbit antithymocyte globulin (ATG). Results The procedure was well tolerated with anticipated cytopenias, neutropenic fever, and fluid overload that were easy to manage and without mortality. The median days for neutrophil and platelet engraftment were 8 (range 7–9) and 8 (range 0–10), respectively. The median infused CD34+ and CD3+ cell counts were 8.31 x 106/kg (range 2.35–14.7) and 2.03 x 108/kg (range 0.41–6.83), respectively. There was a marked improvement of skin score in all subjects, whereas cardiac (ejection fraction, pulmonary arterial pressure), pulmonary function (DLCO) and renal function (creatinine) remained stable. One patient with advanced disease with poor performance status died 2 years after the transplant with progressive disease. After median follow-up of 20 months (range 5–32), the overall survival is 89% (eight out of nine) and progression-free survival with continuing improvement is 67% (six out of nine. 2 patients developed recurrence of skin tightness without compromising organ function. Both of them were placed on mycophenolate mofetil with gradual improvement of skin tightness. Conclusion Autologous HSCT with CY/ATG is safe and is effective. A randomized study (ASSIST: American Scleroderma Stem Cell vs. Immune Suppression Trial), comparing HSCT to intravenous pulse cyclophosphamide is now enrolling patients. Figure Figure
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V106.11.2920.2920
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
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    detail.hit.zdb_id: 80069-7
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  • 4
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    Autologous hematopoietic stem cell transplantation in patients with refractory Crohn’s disease
    Elsevier BV ; 2005
    In:  Gastroenterology Vol. 128, No. 3 ( 2005-3), p. 552-563
    Details
    In: Gastroenterology, Elsevier BV, Vol. 128, No. 3 ( 2005-3), p. 552-563
    Type of Medium: Online Resource
    ISSN: 0016-5085
    URL: Article
    DOI: 10.1053/j.gastro.2004.11.051
    RVK:
    XA 44500
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2005
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  • 5
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    Non-Myeloablative Autologous Hematopoietic Stem Cell Transplantation for Systemic Lupus Erythematosus.
    American Society of Hematology ; 2005
    In:  Blood Vol. 106, No. 11 ( 2005-11-16), p. 156-156
    Details
    In: Blood, American Society of Hematology, Vol. 106, No. 11 ( 2005-11-16), p. 156-156
    Abstract: Manifestations of systemic lupus erythematosus (SLE) may in most patients be ameliorated with medications that suppress the immune system. Nevertheless, there remains a subset of SLE patients for whom current strategies are insufficient to control disease. Here we report results of autologous non-myeloablative hematopoietic stem cell transplantation single arm trial performed at Northwestern University Feinberg School of Medicine between February 1997 and January 2005 involving 50 patients with SLE refractory to standard immune suppressive therapies and either organ- or life-threatening visceral involvement. Peripheral blood stem cells were mobilized with cyclophosphamide (2.0 g/m2) and G-CSF (5 ug/kg/day), enriched ex vivo by CD34+ immunoselection, cryopreserved, and reinfused after treatment with cyclophosphamide (200 mg/kg) and equine anti-thymocyte globulin (90 mg/kg). The primary endpoint was survival, both overall survival and disease free survival. Secondary endpoints include systemic lupus erythematosus disease activity index (SLEDAI), serology (ANA and antids DNA), complement (C3 and C4), and changes in renal and pulmonary organ function assessed pre-treatment and 6 months, 12 months and then yearly for 5 years. Fifty patients were enrolled and underwent stem cell mobilization. Two patients died after mobilization, one from disseminated mucormycosis and another from active lupus after postponing the transplant for 4 months. Forty-eight patients underwent lupus non-myeloablative hematopoietic stem cell transplantation with no treatment related mortality. By intention to treat, treatment related mortality was 2% (1/50). With a mean follow-up of 29 months (range 6 month to 7.5 years ), overall survival was 84%, and probability of disease free survival at 5 years post transplant was 50%. Secondary analysis demonstrated stabilization of renal function and statistically significant improvement (p ≤ .05) in SLEDAI, ANA, anti-ds DNA, complement, and DLCO adjusted for hemoglobin (DLCOadj). In treatment refractory SLE, autologous non-myeloablative hematopoietic stem cell transplantation results in marked amelioration of disease activity, long term disease remission, improvement in serologic markers, and either stabilization or reversal of organ dysfunction.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V106.11.156.156
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
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  • 6
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    Autologous Hematopoietic Stem Cell Transplantation without Total Body Irradiation for Diffuse Scleroderma. Rapid Improvement of Skin Score.
    American Society of Hematology ; 2004
    In:  Blood Vol. 104, No. 11 ( 2004-11-16), p. 5195-5195
    Details
    In: Blood, American Society of Hematology, Vol. 104, No. 11 ( 2004-11-16), p. 5195-5195
    Abstract: Background & Aims Scleroderma is an immune mediated vasculopathy of unknown etiology. There is no known therapy that could alter the natural course of the disease. Patients with diffuse cutaneous disease or visceral involvement has an overall 10-year survival of 35 to 68%. Hematopoietic stem cell transplantation (HSCT) has been performed in the US, but with substantial toxicity, may be due to regimens that utilize total body irradiation (TBI). We performed autologous HSCT without TBI. Methods We conducted a phase I HSCT study in 5 patients with diffuse scleroderma with poor clinical features. Candidates were less than 65 years old with modified Rodnan skin score (mRSS) of more than 14 or lung diffusion capacity (DLCO) less than 80%, interstitial lung disease, elevated ESR, renal involvement, or abnormal electrocardiogram. Patients with irreversible end-stage organ involvement were excluded. Peripheral blood stem cells were mobilized with cyclophosphamide and granulocyte colony-stimulating factor. The graft was not manipulated. The conditioning regimen consisted of 200mg/kg cyclophosphamide (CY), and 7.5mg/kg rabbit antithymocyte globulin (ATG). Results The procedure was well tolerated with anticipated cytopenias, neutropenic fever, and fluid overload that were easy to manage and without mortality. The median days for neutrophil and platelet engraftment were 8 (range 7–9) and 8 (range 0–10), respectively. The median infused CD34+ and CD3+ cell counts were 9.27 x 106/kg (range 2.35–14.7) and 2.34 x 108/kg (range 1.48–6.83), respectively. Improvement of mRSS and changes of pulmonary function {DLCO, total lung capacity (TLC)}, cardiac function {left ventricular ejection fraction (LVEF), pulmonary artery pressure (PA pressure)} and renal function (creatinine) pre-HSCT, at 6 months and at 12 months post-HSCT are in table 1. After median follow-up of 19 months (range 8–20), all patients had improvement of skin score while pulmonary, cardiac and renal function remained stable. Conclusion Autologous HSCT with CY/ATG is safe and may be effective. Randomized studies will be needed to confirm the efficacy of this therapy. table 1 patient skin score (mRSS) DLCO % TLC % LVEF % PA pressure mmHg Creatinine mg/dl 1 pre HSCT 26 48 71 60 23 0.7 6 months 13 39 73 63 normal 0.7 12 months 6 44 74 64 20 1 2 pre HSCT 31 86 114 58 33 0.7 6 months 17 62 106 60 unable to obtain 0.8 12 months 17 118 112 60 28 1 3 pre HSCT 31 57 73 70 36 0.8 6 months 18 55 64 60 35 0.7 12 months 18 48 69 65 43 0.7 4 pre HSCT 24 59 83 55 unable to obtain 0.5 6 months 8 52 79 55 26 0.5 12 months 5 45 73 50 unable to obtain 0.4 5 pre HSCT 30 48 94 55 25 0.6 6 months 8 54 80 55 normal 0.7
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V104.11.5195.5195
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2004
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  • 7
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    Antiphospholipid Syndrome in Patients with Systemic Lupus Erythematosus Treated by Autologous Hematopoietic Stem Cell Transplantation.
    American Society of Hematology ; 2004
    In:  Blood Vol. 104, No. 11 ( 2004-11-16), p. 1877-1877
    Details
    In: Blood, American Society of Hematology, Vol. 104, No. 11 ( 2004-11-16), p. 1877-1877
    Abstract: The association of antiphospholipid antibodies (APLA) with either vascular thrombosis or fetal morbidity is known as the antiphospholipid syndrome (APS). Since systemic lupus erythematosus (SLE) is frequently associated with APS, we analyzed 44 patients with severe and refractory SLE involved in a larger study of autologous hematopoietic stem cell transplantation (HSCT) utilizing cyclophosphamide and antithymocyte globulin (ATG) conditioning to determine the efficacy of this treatment in eliminating APLA and preventing recurrent thrombi. The prevalence of SLE-related APS in our patient population was 63% (45% met Sapporo criteria for definite APS, and 18% had history of APLA positivity with associated clinical APS features). Nineteen patients with APS had lupus anticoagulant (LA) and/or high titers of anticardiolipin antibodies (ACLA) at the entry into study. Ten patients were positive for LA. Fourteen patients showed elevated titers of ACLA, IgG and/or IgM. When followed for up to 30 months after autologous HSCT, 70% of initially LA-positive patients became and remained negative for anticoagulant. 79% demonstrated normalization of ACLA titers during maximum of 28 months follow-up. 64% of patients refractory to chronic anticoagulation regimen were able to discontinue from anticoagulation therapy at average of 6 months post-transplant and remained thrombotic events-free and in complete SLE remission for up to 78 months after HSCT. There was no treatment-related mortality or severe adverse events, including stem cell engrafment-related hematological complications or overhelming bacterial, fungal or viral infection, in any of the 28 SLE-related APS patient. Autologous hematopoietic stem cell transplantation may be performed safely and appears to be effective therapy for eliminating SLE-related APLA and preventing further thrombotic events.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V104.11.1877.1877
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2004
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  • 8
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    Mobilization, Harvesting and Selection of Peripheral Blood Stem Cells in Patients with Autoimmune Diseases Undergoing Non-Myeloablative Autologous Hematopoietic Stem Cell Transplantation.
    American Society of Hematology ; 2005
    In:  Blood Vol. 106, No. 11 ( 2005-11-16), p. 1980-1980
    Details
    In: Blood, American Society of Hematology, Vol. 106, No. 11 ( 2005-11-16), p. 1980-1980
    Abstract: We have analyzed peripheral blood stem cell (PBSC) mobilization, harvesting and selection properties in 128 patients with severe autoimmune diseases undergoing non-myeloablative autologous hematopoietic stem cell transplantation (HSCT) (50 patients with systemic lupus erythematosus (SLE), 43 - with multiple sclerosis (MS), 15 - with Crohn’s disease (CD), 8 - with scleroderma (Scl), and 12 - with others). Female/male ratio and mean age (range) were 90/38 patients, and 34 (14 to 59) years old, respectively. Mobilization regimen included cyclophosphamide 2g/m2 and G-CSF 10 mcg/kg (except for SLE patients 5 mcg/kg). Forty one patients underwent stem cell collection using Baxter CS300, 78 patients - Spectra, and for 9 patients both apheresis machines were utilized. The mean number of aphereses was 1.8 (range 1–10). Patients with SLE required the largest number of apheresis sessions (mean 2.4), comparing to patients with CD (mean 1.9), Scl (mean 1.4), MS (mean 1.3). Five patients additionally required bone marrow harvest for collection of adequate numbers of stem cells. One patient failed to reach CD34+ cell number of 1.0x106/kg, therefore did not proceed to HSCT. The mean number of CD34+ cells in each apheresis unit was 6.07+−6.96x106/kg (the highest of 9.22+−8.52x106/kg in patients with MS, and the lowest of 3.93+−4.48x106/kg in patients with SLE). Ninety eight patients underwent stem cell selection with CEPRATE SC (N=18), Isolex 300iv1.12 (N=2) or Isolex 300iv2.5 (N=78) stem cell concentrator. The mean purity of selected products was 74.3% (the highest of 81.1% attained in patients with Scl); mean recovery of CD34+cells was 61.2%. T cell reduction by average of 3.7 logs was achieved. The mean number of infused CD34+ cells was 7.24+−5.5x106/kg. The highest mean number of CD34+ cells/kg were infused to patients with MS (9.04+−6.74x106/kg), the lowest - to patients with SLE (5.78+−4.13x106/kg). We found a moderate positive correlation between peripheral blood (PB) CD34+ cells/ul and PB WBC/ul (R=0.34, p 〈 0.05), PB platelets/ul (R=0.51, p 〈 0.05) and a strong positive correlation between PB CD34+ cells/ul and the number of CD34+ cells/kg/apheresis (R=0.67, p 〈 0.05). A weak positive correlation was observed between the number of infused CD34+cells/kg and faster WBC engraftment (ANC 〉 500) and platelet engraftment (platelet count 〉 20K). There was no toxicity observed in our patient population during peri-mobilization period except for 1 patient with SLE who died of disseminated mucormycosis 1 week after stem cell collection. Mobilization and selection of PBSC are safe and efficient in patients with severe autoimmune diseases undergoing non-myeloablative autologous HSCT.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V106.11.1980.1980
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
    detail.hit.zdb_id: 1468538-3
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  • 9
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    Online Resource
    Antiphospholipid syndrome in patients with systemic lupus erythematosus treated by autologous hematopoietic stem cell transplantation
    American Society of Hematology ; 2005
    In:  Blood Vol. 106, No. 8 ( 2005-10-15), p. 2700-2709
    Details
    In: Blood, American Society of Hematology, Vol. 106, No. 8 ( 2005-10-15), p. 2700-2709
    Abstract: Systemic lupus erythematosus (SLE) is the most common disease associated with antiphospholipid syndrome (APS). We, therefore, evaluated 46 patients with refractory SLE treated by autologous hematopoietic stem cell transplantation (HSCT) for a history of APS prior to transplantation. The prevalence of SLE-related APS in our patient population was 61% (28 of 46 patients with refractory SLE). Nineteen of 28 patients with APS had lupus anticoagulant (LA) or high titers of anticardiolipin antibodies (ACLAs), either immunoglobulin (Ig)G or IgM, when evaluated at study entry. Six of 8 evaluable LA+ patients became and remained LA–; 5 of 7 initially ACLA IgG+ patients and 9 of 11 ACLA IgM+ patients demonstrated normalization of ACLA titers when followed after HSCT. Eighteen of 22 patients refractory to chronic anticoagulation discontinued anticoagulation therapy a median of 4 months after transplantation; 78% of them remained free of thrombotic events and in complete SLE remission for up to 78 months (median, 15 months) after HSCT. There was no treatment-related mortality. Autologous HSCT may be performed safely in patients with APS and appears to be effective therapy for eliminating ALPAs and preventing thrombotic complications in patients with SLE.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2005-01-0330
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
    detail.hit.zdb_id: 1468538-3
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  • 10
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    Online Resource
    Development of a secondary autoimmune disorder after hematopoietic stem cell transplantation for autoimmune diseases: role of conditioning regimen used
    American Society of Hematology ; 2007
    In:  Blood Vol. 109, No. 6 ( 2007-03-15), p. 2643-2548
    Details
    In: Blood, American Society of Hematology, Vol. 109, No. 6 ( 2007-03-15), p. 2643-2548
    Abstract: Patients undergoing autologous hematopoietic stem cell transplantation (auto-HSCT) for autoimmune disease may have an added propensity to develop a second autoimmune disorder, given the genetic predisposition to autoimmunity. Therefore, we undertook a retrospective analysis of all patients who have undergone auto-HSCT for an autoimmune disease in our institution to determine the occurrence of a second autoimmune disorder and possible risk factors. In all, 155 patients underwent auto-HSCT for various autoimmune diseases; of those patients, 6 manifested a distinct secondary autoimmune disease at a median of 8.5 months (range, 2-30 months) after auto-HSCT. There were 2 patients with systemic lupus erythematosus, conditioned with a regimen containing antithymocyte globulin (ATG), who developed factor VIII inhibitors with severe bleeding. There were 4 patients (2 with multiple sclerosis, one each with lupus and systemic sclerosis) who received an alemtuzumab-containing conditioning regimen who developed autoimmune cytopenias. Among the 155 patients, the frequency of secondary autoimmune complications was 16.0% with alemtuzumab (4/25), 1.9% for ATG (2/102), and 0% for conditioning regimens without lympho-depleting antibodies (0/28)—a difference that was found to be significantly higher with alemtuzumab exposure (P = .011). In contrast, sex, type of ATG used, and CD34-selection of peripheral blood stem cells were not found to be significantly associated with development of a secondary autoimmune disorder.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2006-07-035766
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    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2007
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