Trial · NCT01816230
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM
NCT01816230, Phase 1, Phase 2, Completed, Gamida Cell ltd; results first posted 2020-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM. Trials, record NCT01816230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01816230
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM
- NCT number
- NCT01816230
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Gamida Cell ltd
- Conditions
- Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
- Interventions
- NiCord®
- First posted
- 2013-03-22
- Last updated
- 2020-10-22
- Results first posted
- 2020-09-21
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Engraftment | 42 days | Assess the cumulative incidence of patients with NiCord®-derived neutrophil engraftment at 42 days following transplantation. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Engraftment | 42 days | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Engraftment | NiCord® | 94 | percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NiCord® | 36 | |
| Overall Study | COMPLETED | NiCord® | 36 | |
| Overall Study | NOT COMPLETED | NiCord® | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Decreased appetite | Metabolism and nutrition disorders | NiCord® | 9 | 36 | |
| other | Hypertension | Vascular disorders | NiCord® | 13 | 36 | |
| other | Leukemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NiCord® | 5 | 36 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | NiCord® | 6 | 36 | |
| other | GvHD | Immune system disorders | NiCord® | 6 | 36 | |
| serious | Infection | Infections and infestations | NiCord® | 17 | 36 | |
| serious | GvHD | Immune system disorders | NiCord® | 11 | 36 | |
| serious | Hematologic Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NiCord® | 8 | 36 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NiCord® | 16 | 36 |
| Total, other adverse events | NiCord® | 36 | 36 |
| Total, serious adverse events | NiCord® | 34 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30523748 | DERIVED |
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/NCT01816230
GET https://conductscience.org/api/trials/v1/NCT01816230/registered