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

Bone Marrow Donor Clinical Trial

— SYMBOLpreclini  

Official title:

Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn SyMbOL Pre Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967275
• Other study ID #: EGN_2018_11
• Status: Completed
• Start date: September 9, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Donor

Intervention

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

Locations

Country	Name	City	State
France	Saint Louis Hospital, APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of donors needed to obtain 3 BM harvest.		6 months