Trial · NCT00787722
Hematopoietic Stem Cell Transplant in Devic's Disease
NCT00787722, Phase 1, Phase 2, Completed, Northwestern University; results first posted 2020-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hematopoietic Stem Cell Transplant in Devic's Disease. Trials, record NCT00787722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00787722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hematopoietic Stem Cell Transplant in Devic's Disease
- NCT number
- NCT00787722
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Devic's Disease
- Interventions
- Hematopoietic Stem Cell Transplantation, Cyclophosphamide, G-CSF, rATG, Mesna, Rituximab, Methylprednisolone
- First posted
- 2008-11-07
- Last updated
- 2020-02-28
- Results first posted
- 2020-02-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant | survival rate will be evaluated at 6 months,1 year, 2 year, 3 year, 4 year, 5 year after the transplant |
| Secondary | Quality of Life (QOL) Short Form - 36 (SF-36) | pre-transplant 12mo and 5 years | SF- 36 is a self-administered quality of life exam. The evaluation of the results was done by attributing scores to each question, which were then transformed into a scale ranging from 0 to 100, where 0 corresponds to the worst quality of life and 100 to the best. |
| Secondary | Post HSCT Immune -Modulating Medication and Relapse | Pre transplant and 6 months, 1 year, 2 year, 3 year, 4 year and 5 year after transplant | Number of immune - modulating medication and relapse evaluated 5 year - after the transplant |
| Secondary | Number of Patients Who Require No Device Assistance for Ambulation | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant | No Device Assistance Needed for Ambulation evaluated at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant |
| Secondary | Disability Score: Expanded Disability Status Scale (EDSS) | pretransplant 6 month, 5 year | Disability scores (disease improvement defined by at least a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least three months apart. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. |
| Secondary | NMO-IgG Aquaporin- 4 Autoantibody Titer | Pretransplant and 5 year Post Transplant | NMO-IgG aquaporin- 4 autoantibody titer will be tested pretransplant and post transplant. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant | The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life (QOL) Short Form - 36 (SF-36) | pre-transplant 12mo and 5 years | The reason that the number analyzed differs in one or more rows is because 1 patient did not complete the form and was excluded. Another patient was not 5 years out from transplant so there is no 5 year data on the patient. | score on a scale | MEDIAN |
| SECONDARY | Post HSCT Immune -Modulating Medication and Relapse | Pre transplant and 6 months, 1 year, 2 year, 3 year, 4 year and 5 year after transplant | The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Require No Device Assistance for Ambulation | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant | The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disability Score: Expanded Disability Status Scale (EDSS) | pretransplant 6 month, 5 year | The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant. | score on a scale | MEAN |
| SECONDARY | NMO-IgG Aquaporin- 4 Autoantibody Titer | Pretransplant and 5 year Post Transplant | The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival | Hematopoietic Stem Cell Transplantation | 6 months survival | 13 | Participants | |
| Survival | Hematopoietic Stem Cell Transplantation | 1 year survival | 12 | Participants | |
| Survival | Hematopoietic Stem Cell Transplantation | 2 year survival | 12 | Participants | |
| Survival | Hematopoietic Stem Cell Transplantation | 3 year survival | 11 | Participants | |
| Survival | Hematopoietic Stem Cell Transplantation | 4 year survival | 11 | Participants | |
| Survival | Hematopoietic Stem Cell Transplantation | 5 year survival | 11 | Participants | |
| Quality of Life (QOL) Short Form - 36 (SF-36) | Hematopoietic Stem Cell Transplantation | Pretransplant | 30.83 | Standard Deviation 34.22 | score on a scale |
| Quality of Life (QOL) Short Form - 36 (SF-36) | Hematopoietic Stem Cell Transplantation | 1 Year Post Transplant | 52.69 | Standard Deviation 55.08 | score on a scale |
| Quality of Life (QOL) Short Form - 36 (SF-36) | Hematopoietic Stem Cell Transplantation | 5 Year Post Transplant | 61.63 | Standard Deviation 62.09 | score on a scale |
| Post HSCT Immune -Modulating Medication and Relapse | Hematopoietic Stem Cell Transplantation (HSCT) | Pre HSCT - Immunosuppression/Relapse Rate | 12 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hematopoietic Stem Cell Transplantation | 13 | |
| Overall Study | COMPLETED | Hematopoietic Stem Cell Transplantation | 12 | |
| Overall Study | NOT COMPLETED | Hematopoietic Stem Cell Transplantation | 1 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infection | Infections and infestations | Hematopoietic Stem Cell Transplantation | 1 | 13 | 1 |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Hematopoietic Stem Cell Transplantation | 9 | 13 | 9 |
| other | Neutropenic Fevers | General disorders | Hematopoietic Stem Cell Transplantation | 5 | 13 | 5 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Hematopoietic Stem Cell Transplantation | 3 | 13 | 3 |
| other | Nausea and Vomiting | Metabolism and nutrition disorders | Hematopoietic Stem Cell Transplantation | 3 | 13 | 3 |
| other | Hypokalemia | Metabolism and nutrition disorders | Hematopoietic Stem Cell Transplantation | 2 | 13 | 2 |
| other | Orthostatic Hypotension | General disorders | Hematopoietic Stem Cell Transplantation | 2 | 13 | 2 |
| other | Hypertension, Hyperglycemia, Diarrhea | General disorders | Hematopoietic Stem Cell Transplantation | 1 | 13 | 1 |
| serious | Unrelated Complications from Systemic Lupus Erythematosus | Immune system disorders | Hematopoietic Stem Cell Transplantation | 1 | 13 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hematopoietic Stem Cell Transplantation | 1 | 13 |
| Total, other adverse events | Hematopoietic Stem Cell Transplantation | 9 | 13 |
| Total, serious adverse events | Hematopoietic Stem Cell Transplantation | 1 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31578302 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00787722
GET https://conductscience.org/api/trials/v1/NCT00787722/results?page=2