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

NCT ID: NCT03967275

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-09

Study Completion Date

2022-06-01

Brief Summary

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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

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Conditions

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Bone Marrow Donor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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bone marrow harvest

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint Louis Hospital, APHP

Paris, , France

Site Status

Countries

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France

Other Identifiers

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EGN_2018_11

Identifier Type: -

Identifier Source: org_study_id

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