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

Completed

• Conditions: Bone Marrow Donor

• Registration Number: NCT03967275
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-26
• Study First Submitted QC: 2019-05-26
• Study First Posted: 2019-05-30
• Study Start: 2020-09-09
• Status Verified: 2022-06
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of donors needed to obtain 3 BM harvest.	6 months

Trial Locations

Locations (1)

Saint Louis Hospital, APHP; 🇫🇷 Paris, France