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Collection and Characterisation of Human Olfactory Ensheathing Cells

NCT02870426 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2018-05-04

No results posted yet for this study

Summary

We aim to retrieve olfactory bulbs (OBs) from suitable human donors. We have defined two groups who will qualify:

Group 1 - Deceased Donors:

1A: Donors after brainstem death (DBDs) undergoing solid organ donation

1B: Donors after brainstem death (DBDs) considered unsuitable for solid organ donation

Group 2 - Living Donors:

Neurosurgical patients undergoing anterior cranial surgery in which the olfactory nerve (ON) is cut as part of the surgical procedure. The OB of the concomitant severed ON would be donated.

We aim to optimise OB collection and Olfactory Ensheathing Cell (OEC) culture and storage. We will study the effects of patient diagnosis, age, cause of death (if applicable), co-morbidities and warm ischaemic time on cell survival and regenerative function.

In future studies we aim to store OECs in a GMP facility and transplant OECs into patients with spinal cord injuries.

Conditions

  • Spinal Cord Injury

Interventions

PROCEDURE

Frontal Craniotomy and retrieval of OBs

For Group 1A the craniotomy will occur during organ retrieval for transplantation under aseptic technique. For Group 1B it would occur as a separate surgical procedure prior to palliation under full asepsis.

PROCEDURE

OB Retrieval During Anterior Cranial Surgery

Group 2: The patients routine anterior cranial surgery would proceed as planned without change to the surgical procedure. In the event that the ON had to be sacrificed for the purposes of surgery the OB of the concomitant nerve would be retrieved.

Sponsors & Collaborators

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Marios Papadopoulos, FRCS (SN) · St George's, University of London

  • Samira Saadoun, PhD · St George's, University of London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2021-06-30
Completion
2023-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02870426 on ClinicalTrials.gov