Trial · NCT05559801
Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)
NCT05559801, Phase 1, Phase 2, Not yet recruiting, Emory University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI). Trials, record NCT05559801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05559801
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)
- NCT number
- NCT05559801
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 12 participants, estimated
- Lead sponsor
- Emory University
- Conditions
- Osteogenesis Imperfecta, Osteogenesis Imperfecta Type III
- Interventions
- Bone marrow-derived mesenchymal stromal cells (MSCs)
- First posted
- 2022-09-29
- Last updated
- 2026-05-08
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment rate of participants | Up to 24 months post-intervention | Number of participants consented at the end of the trial |
| Primary | Number of participants with correctly collected data for the study outcomes | Up to 24 months post-intervention | Number of participants with data correctly collected for the study outcomes |
| Primary | Total number of visits with protocol deviation | Up to 24 months post-intervention | Total number of visits with protocol deviations at the end of the trial |
| Primary | Visit attendance by participants | Up to 1 year post last infusion intervention | Percentage of visits completed by participants |
| Primary | Patient retention rate | Up to 1 year post last infusion intervention | Percentage of patients that complete the study intervention and all follow up study visits |
| Primary | Patient Primary Clinical Outcome Retention Rate | Up to 1 year post last infusion intervention | Percentage of participants that completed the primary clinical outcome measurements |
| Primary | Change in acceptability from baseline | Baseline, Up to 36 months post-intervention | Acceptability will be evaluated with an end of study structured, verbal interview. This interview will consist of a mix of closed ended (scaled questions from 1\[worst\]-5 \[best\]) and open-ended questions giving subjective measurements. Open-ended questions will address overall experience during the study and prompt expression of thoughts or perspectives after completing the study. The total possible score range is 18 to 90. Higher score correlates with better outcome. |
| Primary | Number of unexpected adverse events | Up to 1 year post last infusion intervention | Unexpected adverse events that occur from first study intervention to one year after last infusion. |
| Primary | Number of participants with change in vital signs from baseline | Baseline, 10 minutes pre-intervention, 15 minutes post-intervention, 30 minutes post-intervention, 1 hour post-intervention, 1 hour post completion of the infusion | Number of participants with blood pressure, oxygen saturation, heart rate, respiratory rate, and temperature below or above each participants accepted mean reference range. |
| Primary | Number of participants with changes in laboratory panels from baseline (CBC, CMP) | Baseline, every 4 months post-intervention | Number of patients with changes in CBC or CMP values from baseline CBC or CMP values. Any evidence of thrombocytopenia, anemia, neutropenia, or elevations in white blood counts will require consideration of stopping or pausing infusions by the PI. Slight changes in the ALT, AST, and calcium values are expected due to standard medication uses and will be monitored by PI. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
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/NCT05559801
GET https://conductscience.org/api/trials/v1/NCT05559801/registered