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Clinical, Journal: Long term outcomes of the French ASTIS systemic sclerosis cohort using the global rank composite score. (Pubmed Central) - Oct 15, 2021 Two randomised trials (ASTIS, SCOT) of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) versus monthly Cyclophosphamide for severe Systemic Sclerosis (SSc) patients used similar inclusion criteria, but different primary endpoints: event-free-survival (EFS) at 24 months in ASTIS versus the global rank composite score (GRCS) at 54 months in SCOT...In intention-to-treat analysis, the GRCS demonstrated superiority for AHSCT (median: 9 versus -19, p = 0.018), mRSS (Δ mRSS: -16 versus -9, p = 0.02), and HAQ-DI (ΔHAQ-DI: -0.89 versus -0.2, p = 0.05) with no significant difference in OS, EFS, lung, heart and kidney function between the groups. In conclusion, this study demonstrates long term benefits of non-myeloablative AHSCT when assessed by the five longitudinal measures within GRCS affording direct primary endpoint comparison between ASTIS and SCOT.
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Review, Journal: New autoimmune diseases after autologous hematopoietic stem cell transplantation for multiple sclerosis. (Pubmed Central) - Jul 28, 2021 Alemtuzumab in the conditioning regimen has been identified as a risk for development of 2ndADs after either allogeneic or autologous HSCT and is consistent with the high rates of 2ndADs when using alemtuzumab as monotherapy. Due to the significant consequences but variable incidence, depending on conditioning regimen, of 2ndADs and similarity in known immune reconstitution kinetics after autologous HSCT for autoimmune diseases and after alemtuzumab monotherapy, we propose that an imbalance between B and T lineage regeneration early after HSCT may underlie the pathogenesis of 2ndADs.
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Journal: Hematopoietic stem cell transplantation for chronic inflammatory demyelinating polyradiculoneuropathy. (Pubmed Central) - Jun 22, 2021 Due to the significant consequences but variable incidence, depending on conditioning regimen, of 2ndADs and similarity in known immune reconstitution kinetics after autologous HSCT for autoimmune diseases and after alemtuzumab monotherapy, we propose that an imbalance between B and T lineage regeneration early after HSCT may underlie the pathogenesis of 2ndADs. A randomized trial is indicated to verify these results and confirm that HSCT reverses disability and offers long-term immune therapy independence.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Lemtrada (alemtuzumab) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
[VIRTUAL] OUTCOME OF NON-MYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MULTIPLE SCLEROSIS: A SINGLE CENTER SUMMARY OF 511 PATIENTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2152; The low incidence of bacteremia may be related to the use of non-myeloablative regimens that do not cause mucositis, i.e. gut endothelium bacterial barrier remains closed, placement and removal of the large bore apheresis catheter on the same day and subsequent insertion of a PICC line in the upper inner arm on day of admission resulting in less risk of cutaneous barrier breaches, a HEPA-filtered floor, and to the use of pre-emptive antibiotics when neutropenic. On the other hand, one patient developed legionella pneumonia that was subsequently cultured from the showerhead.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Lemtrada (alemtuzumab) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
[VIRTUAL] OUTCOME OF NON-MYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MULTIPLE SCLEROSIS: A SINGLE CENTER SUMMARY OF 511 PATIENTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2151; The low incidence of bacteremia may be related to the use of non-myeloablative regimens that do not cause mucositis, i.e. gut endothelium bacterial barrier remains closed, placement and removal of the large bore apheresis catheter on the same day and subsequent insertion of a PICC line in the upper inner arm on day of admission resulting in less risk of cutaneous barrier breaches, a HEPA-filtered floor, and to the use of pre-emptive antibiotics when neutropenic. On the other hand, one patient developed legionella pneumonia that was subsequently cultured from the showerhead.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Lemtrada (alemtuzumab) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
[VIRTUAL] OUTCOME OF NON-MYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MULTIPLE SCLEROSIS: A SINGLE CENTER SUMMARY OF 511 PATIENTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2150; The low incidence of bacteremia may be related to the use of non-myeloablative regimens that do not cause mucositis, i.e. gut endothelium bacterial barrier remains closed, placement and removal of the large bore apheresis catheter on the same day and subsequent insertion of a PICC line in the upper inner arm on day of admission resulting in less risk of cutaneous barrier breaches, a HEPA-filtered floor, and to the use of pre-emptive antibiotics when neutropenic. On the other hand, one patient developed legionella pneumonia that was subsequently cultured from the showerhead.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Lemtrada (alemtuzumab) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
[VIRTUAL] OUTCOME OF NON-MYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR MULTIPLE SCLEROSIS: A SINGLE CENTER SUMMARY OF 511 PATIENTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_2149; The low incidence of bacteremia may be related to the use of non-myeloablative regimens that do not cause mucositis, i.e. gut endothelium bacterial barrier remains closed, placement and removal of the large bore apheresis catheter on the same day and subsequent insertion of a PICC line in the upper inner arm on day of admission resulting in less risk of cutaneous barrier breaches, a HEPA-filtered floor, and to the use of pre-emptive antibiotics when neutropenic. On the other hand, one patient developed legionella pneumonia that was subsequently cultured from the showerhead.
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Trial termination: Stem Cell Transplantation for Stiff Person Syndrome (SPS) (clinicaltrials.gov) - Jan 6, 2021 P1/2, N=23, Terminated, Long-term follow-up will be essential for assessing the quality of life after this regimen. Active, not recruiting --> Terminated; Could not predict who would respond, relapse or go into remission
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: CAST: Cardiac Safe Transplants for Systemic Sclerosis (clinicaltrials.gov) - Aug 12, 2020 P2/3, N=9, Terminated, Safety is consistent with that of single-agent busulfan myeloablation. N=50 --> 9 | Trial completion date: Jan 2026 --> Oct 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Oct 2019; PI Sabbatical
- |||||||||| autologous hematopoietic stem cell therapy / Northwestern University
Trial completion, Trial completion date: Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy (clinicaltrials.gov) - Jul 23, 2020 P2, N=80, Completed, N=50 --> 9 | Trial completion date: Jan 2026 --> Oct 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Oct 2019; PI Sabbatical Active, not recruiting --> Completed | Trial completion date: Jul 2020 --> Nov 2019
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Trial completion date, Trial primary completion date: Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy (clinicaltrials.gov) - Nov 10, 2019 P2, N=80, Active, not recruiting, Clinical Trial Registry: FDA IND 16908, www.clinicaltrials.gov NCT 01288053 Trial completion date: Jan 2020 --> Jul 2020 | Trial primary completion date: Dec 2018 --> Jul 2019
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Enrollment change, Trial withdrawal: ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - Nov 8, 2019 P2/3, N=0, Withdrawn, Trial completion date: Jan 2020 --> Jul 2020 | Trial primary completion date: Dec 2018 --> Jul 2019 N=50 --> 0 | Recruiting --> Withdrawn
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Trial initiation date: ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - Jul 25, 2019 P2/3, N=50, Recruiting, Additionally, pre-treatment with a checkpoint inhibitor prior to autoHSCT appears safe thus far and does not appear to delay engraftment. Initiation date: Jun 2019 --> Nov 2019
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Enrollment closed: CAST: Cardiac Safe Transplants for Systemic Sclerosis (clinicaltrials.gov) - Jul 25, 2019 P2/3, N=50, Active, not recruiting, Initiation date: Jun 2019 --> Nov 2019 Recruiting --> Active, not recruiting
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Trial initiation date: ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - May 2, 2019 P2/3, N=50, Recruiting, Recruiting --> Active, not recruiting Initiation date: Mar 2019 --> Jun 2019
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment closed, Enrollment change: Stem Cell Transplantation for Stiff Person Syndrome (SPS) (clinicaltrials.gov) - Jan 31, 2019 P1/2, N=23, Active, not recruiting, Trial completion date: Dec 2018 --> Jan 2020 | Trial primary completion date: Feb 2018 --> Dec 2018 Recruiting --> Active, not recruiting | N=40 --> 23
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
New P2/3 trial: CAST: Cardiac Safe Transplants for Systemic Sclerosis (clinicaltrials.gov) - Jul 20, 2018 P2/3, N=50, Recruiting,
- |||||||||| Enrollment change, Trial termination, Trial primary completion date: Hematopoietic Stem Cell Support in Vasculitis (clinicaltrials.gov) - Jul 13, 2016
P1, N=7, Terminated, N=10 --> 7 | Recruiting --> Terminated | Trial primary completion date: Aug 2017 --> Jun 2016; No participant enrolled over five years. No plan to continue the study.
- |||||||||| Trial primary completion date: Hematopoietic Stem Cell Support in Vasculitis (clinicaltrials.gov) - Mar 22, 2016
P1, N=10, Recruiting, Trial primary completion date: Dec 2016 --> Dec 2017 Trial primary completion date: Aug 2016 --> Aug 2017
- |||||||||| autologous hematopoietic stem cell therapy / Northwestern University
Enrollment change, Trial termination, Trial primary completion date: Hematopoietic Stem Cell Support in Patients With Refractory Sarcoidosis (clinicaltrials.gov) - Sep 23, 2015 P1/2, N=2, Terminated, N=50 --> 80 N=10 --> 2 | Recruiting --> Terminated | Trial primary completion date: Dec 2017 --> Aug 2015; No plan to continue enrollment
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