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Completed

NCT Number: NCT03967275

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

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.

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Key information

Conditions

Bone Marrow Donor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Louis Hospital, APHP

Paris, 75010, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bone marrow harvest

Other

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

Primary outcomes

  1. The number of donors needed to obtain 3 BM harvest.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: SYMBOLpreclini

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 30, 2019
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.