Trial · NCT06676423
Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS
NCT06676423, Phase 1, Completed, Corestemchemon, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS. Trials, record NCT06676423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06676423
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS
- NCT number
- NCT06676423
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- Corestemchemon, Inc.
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Lenzumestrocel, Riluzole
- First posted
- 2024-11-06
- Last updated
- 2024-11-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | tolerability Assessment | through study period, an average of 8week | HTS-FRS DLT expression for each dose step |
| Primary | Safety Assessment | through study period, an average of 8week | Adverse Events(including DLT) |
| Primary | Safety Assessment | Baseline and 26day, 8week | Clinical Laboratory Analysis(Change in laboratory test results at the time of visit after IP administration compared to baseline) |
| Primary | Safety Assessment | 0 Day, 26 Day | Cerebrospinal Fluid Analysis(Changes in cerebrospinal fluid results at 26day compared to 0day) |
| Secondary | Exploratory Assessment | baseline and 26day , 8week | Change in total ALSFRS-R score from before treatment (screening) to after administration |
| Secondary | Exploratory Assessment | within -8week and 0day, 8week | Change rate in ALSFRS-R score from before treatment (screening) to after administration |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06676423
GET https://conductscience.org/api/trials/v1/NCT06676423/registered