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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03967275
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.


Condition or disease Intervention/treatment
Bone Marrow Donor Other: bone marrow harvest

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Study Type : Observational
Estimated Enrollment : 3 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn SyMbOL Pre Clinical Study
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : November 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns


Intervention Details:
  • Other: bone marrow harvest
    During bone marrow harvest, an additional 10 mL sample will be collected for the study.


Primary Outcome Measures :
  1. The number of donors needed to obtain 3 BM harvest. [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Bone marrow donors
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967275


Contacts
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Contact: Eric Gabison +33148036484 egabison@for.paris
Contact: Amélie Yavchitz +33148036454 ayavchitz@for.paris

Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03967275    
Other Study ID Numbers: EGN_2018_11
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Bone marrow harvest
Bone Marrow derived Mesenchymal Stem Cells (BM-MSC)
Pre-clinical
Additional relevant MeSH terms:
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Burns, Chemical
Burns
Wounds and Injuries