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Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn (SyMbOL)

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ClinicalTrials.gov Identifier: NCT03967275
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date May 26, 2019
First Posted Date May 30, 2019
Last Update Posted Date April 9, 2021
Actual Study Start Date September 9, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2019)
The number of donors needed to obtain 3 BM harvest. [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn
Official Title Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn SyMbOL Pre Clinical Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Bone marrow donors
Condition Bone Marrow Donor
Intervention Other: bone marrow harvest
During bone marrow harvest, an additional 10 mL sample will be collected for the study.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 26, 2019)
3
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2030
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

- Patient with a bone marrow donation planned

Exclusion criteria:

  • The donor is finally not eligible
  • The harvest cannot be performed
  • The sample cannot be obtained during the BM harvest procedure
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Eric Gabison +33148036484 egabison@for.paris
Contact: Amélie Yavchitz +33148036454 ayavchitz@for.paris
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03967275
Other Study ID Numbers EGN_2018_11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date April 2021