Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn
SYMBOLpreclini
1 other identifier
observational
7
1 country
1
Brief Summary
The objective of this pre-clinical study is to demonstrate the robustness of Bone Marrow derived Mesenchymal Stem Cells (BM-MSC) production, to treat patients with severe eye burns. For bone marrow donors who agree to participate, a 10 ml BM sample will be collected apart the 1 liter BM dedicated to transplantation. A maximum of three donors of allogeneic BM-MSCs will be included. A ready-to-use BM-MSC suspension will be produced and stored for 10 years to accumulate data about stability of cryopreserved cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedStudy Start
First participant enrolled
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 5, 2022
June 1, 2022
1.7 years
May 26, 2019
June 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of donors needed to obtain 3 BM harvest.
6 months
Interventions
During bone marrow harvest, an additional 10 mL sample will be collected for the study.
Eligibility Criteria
Bone marrow donors
You may qualify if:
- \- Patient with a bone marrow donation planned
You may not qualify if:
- The donor is finally not eligible
- The harvest cannot be performed
- The sample cannot be obtained during the BM harvest procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Louis Hospital, APHP
Paris, 75010, France
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2019
First Posted
May 30, 2019
Study Start
September 9, 2020
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
July 5, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share