Table 5. Hematopoietic stem cell transplantation for multiple sclerosis disease.
Cell type | Years | Country | Phase | Evaluation after cell therapy | NCT number (clinicaltrials.gov) |
---|---|---|---|---|---|
Autologous HSCs | 2007–2018 | Switzerland | 1 & 2 | Safe delivery of hematopoietic stem cell after infusion. Stem cell engraftment and disease remission after 3 years | NCT00497952 |
Autologous HSCs | 2015 | Philippines | 1 | Safety and efficacy after cell therapy, measurement of quality of life by change in baseline of RAND-36 score | NCT03113162 |
Autologous HSCs | 2006–2014 | USA | 1 & 2 | Disease progression is defined as a 1-point increase in the EDSS on consecutive evaluations, data are reporting the number of participants who survived three years after the transplant, survival of 21 participants was evaluated at three years after the transplant | NCT00278655 |
Autologous HSCs | 2016–2018 (60) | Mexico | 1 | There were no transplant-related deaths and the 128-month overall survival of the patients is 100%. In 82 persons followed up for 3 or more months, the Expanded Disability Status Scale diminished from a mean of 5.2 to 4.9, the best results being obtained in relapsing-remitting and primary progressive MS | NCT02674217 |
Autologous HSCs | 2006–2017 | USA | 2 | There was any outcome from this research in ClinicalTrials.gov and any publication | NCT00342134 |
Autologous HSCs | 2018 | Norway | 3 | Proportion of patients with no evidence of disease activity, difference in patient reported quality of life based on the EuroQoL Health Related Quality of Life-5 Dimensions-5 Levels (EQ-5D 5L) scores, time to first sign of new disease activity, as measured as new relapses, EDSS-progression, MRI-activity or brain atrophy | NCT03477500 |
Autologous HSCs | 2012–2013 | USA | 2 | Effectiveness of high dose chemotherapy with HPC transplant for multiple sclerosis that has failed at least two lines of therapy, Subsequent MRI scan will be determined by the patient's neurologist as is needed clinically. | NCT01679041 |
Autologous HSCs | 2010–2016 (61,62) | Canada | 2 | The median FIS score decreased 36%, from 36 to 23, and four patients had 100% reduction. Patients had significantly less fatigue on average after a HSCT. This may serve to better understand the contribution of ongoing CNS inflammation to fatigue peculiar to MS. 35% of patients had a sustained improvement in their EDSS score. | NCT01099930 |
Autologous HSCs | 2005–2018 (63) | USA & Sweden, and Brazil | 2 | Progression free survival at 5 years. Demonstrate circumstantial evidence for the removal of autoreactive T-cell clones as well as development of tolerance after HSCT. These results parallel the long-term disease remission seen after HSCT. Presence of gadolinium-enhancing lesions prior to HSCT was associated with a favourable outcome | NCT00273364 |
Autologous HSCs | 2006–2017 (64) | USA | 2 | Overall event-free survival was 78.4% at 3 years. Progression-free survival and clinical relapse-free survival were 90.9% and 86.3%, respectively. Adverse events were consistent with expected toxic effects associated with HDIT/HCT, and no acute treatment-related neurologic adverse events were observed. Improvements were noted in neurologic disability, quality-of-life, and functional scores | NCT00288626 |
Autologous HSCs | 2002–2007 | USA | 2 | HSC therapy is safe without side effect after cell injection. EDSS measure after cell therapy | NCT00040482 |
Autologous HSCs | 2017 | USA | 3 | Survival of participants after cell therapy. EDSS Improvement. Supportive confirmation by enhancement on MRI is preferred | NCT03342638 |
HSCs, hematopoietic stem cells; EDSS, Expanded Disability Status Scale; MS, multiple sclerosis; MRI, magnetic resonance imaging; HPC, hematopoietic progenitor cells; FIS, Fatigue Impact Scale; HSCT, hematopoietic stem cell transplantation; CNS, central nervous system; HDIT, high-dose immunosuppressive therapy; HCT, hematopoietic cell transplant; HSC, hematopoietic stem cell.