Trial · NCT02336230
A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)
NCT02336230, Phase 3, Completed, Mesoblast, Inc.; results first posted 2022-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD). Trials, record NCT02336230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02336230
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)
- NCT number
- NCT02336230
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- Mesoblast, Inc.
- Conditions
- Grade B aGVHD, Grade C aGVHD, Grade D aGVHD
- Interventions
- remestemcel-L
- First posted
- 2015-01-12
- Last updated
- 2022-03-17
- Results first posted
- 2022-03-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) at Day 28 Post Initiation of Therapy | Day 28 | ORR was defined as the percentage of participants who had achieved overall response. Overall response was defined as complete response (CR) plus partial response (PR) as per aGVHD response criteria. CR was defined as resolution of aGVHD in all involved organs. PR was defined as organ improvement of at least 1 stage without worsening of any other organ. |
| Secondary | Overall Survival (OS) Rate at Day 100 Post Initiation of Therapy | Day 100 | Overall survival rate was defined as percentage of participants who survived. OS was defined as the time to death from the start of drug therapy. |
| Secondary | OS Rate at Day 100 Post Initiation of Therapy, Stratified by Responder Status at Day 28 | Day 100 | Overall survival rate was defined as percentage of participants who survived. OS was defined as the time to death from the start of drug therapy. |
| Secondary | OS Rate at Day 100 Post Initiation of Therapy, Stratified by Baseline aGVHD Grade | Day 100 | OS rate was defined as percentage of participants who survived. OS was defined as the time to death from the start of drug therapy. Maximum severity of acute GVHD was assessed by using International Bone Marrow Transplant Registry (IBMTR) index. The severity index was defined as: Grade A (skin Stage 1: extent of rash \<25%); Grade B (skin Stage 2: extent of rash 25 to 50% or liver Stage 1 to 2: total bilirubin 34 to 102 micromoles per liter \[mcmol/L\] or intestinal tract Stage 1 to 2: volume of diarrhea 550 to 1500 milliliters per day \[mL/day\]); Grade C (skin Stage 3: extent of rash \> 50% or liver Stage 3: total bilirubin 103 to 255 mcmol/L or intestinal tract Stage 3: volume of diarrhea \>1500 mL/day); Grade D (skin Stage 4: extent of rash bullae or liver Stage 4: total bilirubin \>255 or intestinal tract Stage 4: volume of diarrhea severe pain and ileus). |
| Secondary | OS Rate at Day 100 Post Initiation of Therapy, Stratified by Organ Involvement | Day 100 | OS rate was defined as percentage of participants who survived. OS was defined as the time to death from the start of drug therapy. The data was summarized for organ involvement: skin only, lower GI only, and multi-organ. |
| Secondary | OR Rate at Day 56 and 100 Post Initiation of Therapy | Day 56 and Day 100 | OR rate was defined as the percentage of participants who had achieved overall response. Overall response was defined as CR plus PR as per aGVHD response criteria. CR was defined as resolution of aGVHD in all involved organs. PR was defined as organ improvement of at least 1 stage without worsening of any other organ. |
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 | Overall Response Rate (ORR) at Day 28 Post Initiation of Therapy | Day 28 | FAS included all participants who provided informed consent, were screened, and were found eligible to enter the study. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) Rate at Day 100 Post Initiation of Therapy | Day 100 | FAS included all participants who provided informed consent, were screened, and were found eligible to enter the study. | percentage of participants | NUMBER |
| SECONDARY | OS Rate at Day 100 Post Initiation of Therapy, Stratified by Responder Status at Day 28 | Day 100 | FAS included all participants who provided informed consent, were screened, and were found eligible to enter the study. Number analyzed is the number of participants with data available for given category. | percentage of participants | NUMBER |
| SECONDARY | OS Rate at Day 100 Post Initiation of Therapy, Stratified by Baseline aGVHD Grade | Day 100 | FAS included all participants who provided informed consent, were screened, and were found eligible to enter the study. Number analyzed is the number of participants with data available for given category. | percentage of participants | NUMBER |
| SECONDARY | OS Rate at Day 100 Post Initiation of Therapy, Stratified by Organ Involvement | Day 100 | FAS included all participants who provided informed consent, were screened, and were found eligible to enter the study. Number analyzed is the number of participants with data available for given category. | percentage of participants | NUMBER |
| SECONDARY | OR Rate at Day 56 and 100 Post Initiation of Therapy | Day 56 and Day 100 | FAS included all participants who provided informed consent, were screened, and were found eligible to enter the study. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) at Day 28 Post Initiation of Therapy | Remestemcel-L 2×10^6 MSCs/kg | 69.1 | percentage of participants | ||
| Overall Survival (OS) Rate at Day 100 Post Initiation of Therapy | Remestemcel-L 2×10^6 MSCs/kg | 74.5 | percentage of participants | ||
| OS Rate at Day 100 Post Initiation of Therapy, Stratified by Responder Status at Day 28 | Remestemcel-L 2×10^6 MSCs/kg | Responders | 86.8 | percentage of participants | |
| OS Rate at Day 100 Post Initiation of Therapy, Stratified by Responder Status at Day 28 | Remestemcel-L 2×10^6 MSCs/kg | Non- Responders | 47.1 | percentage of participants | |
| OS Rate at Day 100 Post Initiation of Therapy, Stratified by Baseline aGVHD Grade | Group not reported | Grade A | percentage of participants | ||
| OS Rate at Day 100 Post Initiation of Therapy, Stratified by Baseline aGVHD Grade | Remestemcel-L 2×10^6 MSCs/kg | Grade B | 50.0 | 95% Confidence Interval 11.81 to 88.19 | percentage of participants |
| OS Rate at Day 100 Post Initiation of Therapy, Stratified by Baseline aGVHD Grade | Remestemcel-L 2×10^6 MSCs/kg | Grade C | 82.6 | 95% Confidence Interval 61.22 to 95.05 | percentage of participants |
| OS Rate at Day 100 Post Initiation of Therapy, Stratified by Baseline aGVHD Grade | Remestemcel-L 2×10^6 MSCs/kg | Grade D | 73.1 | 95% Confidence Interval 52.21 to 88.43 | percentage of participants |
| OS Rate at Day 100 Post Initiation of Therapy, Stratified by Organ Involvement | Remestemcel-L 2×10^6 MSCs/kg | Skin Only | 78.6 | percentage of participants | |
| OS Rate at Day 100 Post Initiation of Therapy, Stratified by Organ Involvement | Remestemcel-L 2×10^6 MSCs/kg | Lower GI Only | 76.2 | percentage of participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Remestemcel-L 2×10^6 MSCs/kg | 55 | |
| Overall Study | Full Analysis Set (FAS) | Remestemcel-L 2×10^6 MSCs/kg | 55 | |
| Overall Study | Safety Analysis Population | Remestemcel-L 2×10^6 MSCs/kg | 54 | |
| Overall Study | COMPLETED | Remestemcel-L 2×10^6 MSCs/kg | 42 | |
| Overall Study | NOT COMPLETED | Remestemcel-L 2×10^6 MSCs/kg | 13 |
Source ClinicalTrials.gov
Adverse events130
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 | Anaemia | Blood and lymphatic system disorders | Remestemcel-L 2×10^6 MSCs/kg | 4 | 54 | |
| other | Neutropenia | Blood and lymphatic system disorders | Remestemcel-L 2×10^6 MSCs/kg | 3 | 54 | |
| other | Sinus tachycardia | Cardiac disorders | Remestemcel-L 2×10^6 MSCs/kg | 5 | 54 | |
| other | Pericardial effusion | Cardiac disorders | Remestemcel-L 2×10^6 MSCs/kg | 3 | 54 | |
| other | Tachycardia | Cardiac disorders | Remestemcel-L 2×10^6 MSCs/kg | 3 | 54 | |
| other | Adrenal insufficiency | Endocrine disorders | Remestemcel-L 2×10^6 MSCs/kg | 5 | 54 | |
| other | Cushingoid | Endocrine disorders | Remestemcel-L 2×10^6 MSCs/kg | 5 | 54 | |
| other | Abdominal pain | Gastrointestinal disorders | Remestemcel-L 2×10^6 MSCs/kg | 10 | 54 | |
| other | Vomiting | Gastrointestinal disorders | Remestemcel-L 2×10^6 MSCs/kg | 9 | 54 | |
| other | Diarrhoea | Gastrointestinal disorders | Remestemcel-L 2×10^6 MSCs/kg | 6 | 54 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Remestemcel-L 2×10^6 MSCs/kg | 13 | 55 |
| Total, other adverse events | Remestemcel-L 2×10^6 MSCs/kg | 52 | 54 |
| Total, serious adverse events | Remestemcel-L 2×10^6 MSCs/kg | 35 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32018062 | 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/NCT02336230
GET https://conductscience.org/api/trials/v1/NCT02336230/events?page=2