Collection and Characterisation of Human Olfactory Ensheathing Cells
NCT ID: NCT02870426
Last Updated: 2018-05-04
Study Results
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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UNKNOWN
50 participants
OBSERVATIONAL
2018-04-09
2023-07-31
Brief Summary
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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.
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Detailed Description
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A substantial body of evidence suggests that olfactory ensheathing cells (OECs) obtained from olfactory bulbs (OBs) facilitate neuronal regeneration in rodents and humans with SCI. Indeed, transplanting autologous OECs from an OB into the injury site improved neurological outcome in a patient with SCI.
Harvesting autologous OBs to culture OECs has several disadvantages:
1. If the OECs do not grow in vitro, the transplantation is abandoned;
2. The retrieval procedure exposes a paralysed patient to the risks of craniotomy;
3. Excising an OB can impair the sense of smell; and
4. The number of OECs obtained is limited to one OB.
Investigators will collect human OECs from suitable donors which we have defined as two groups. Group 1 patients will be brain dead donors identified by the neuro-intensive care team as potential candidates for solid organ donation. The OBs will be retrieved as near to death as possible. Group 2 patients will be living donors undergoing elective neurosurgery in which the olfactory nerve is sacrificed as part of that procedure.
There are two OBs located at the anterior skull base, responsible for transmitting the sensation of smell from the nose to the brain. Obtaining OECs requires a craniotomy (opening the skull) to remove the OBs.
PHASE 1 will be divided into 2 stages. In stage 1 we will culture OECs and characterise them in the central laboratory. We aim to determine how the yield of OECs and their regenerative properties are affected by freeze-thaw, time left at room temperature and time left at 40C before culture as well as patient age. Each harvested sample will be transferred to the lab for further processing. Processing includes but is not limited to histological fixation, sectioning and staining, cell culture and storage. Some OECs will be frozen in liquid nitrogen to determine whether they can indeed be stored. In stage 2 we will transfer OECs outside St. George's to a GMP facility (to be determined). In the GMP facility, the OECs will be processed and stored according to the optimised conditions we have determined.
In PHASE 2, the OECs will be transplanted into patients with SCI.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Group 1A:
Donors after brainstem death (DBDs) undergoing solid organ donation
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.
Group 1B:
Donors after brainstem death (DBDs) considered unsuitable for solid organ donation
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.
Group 2:
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
1. Diagnosis of brainstem death, AND
2. Consent from next of kin (NoK) for organ donation
3. Consent from NoK for removal of olfactory bulbs (OBs)
4. Coroner's consent for removal of OBs (when needed).
1B
1. Diagnosis of brainstem death, AND
2. Contraindications for solid organ donation
3. Consent from NoK for removal of OBs
4. Coroners consent for removal of OBs (when needed)
Group 2 - Living Donors
1. Patients having anterior cranial surgery in which the ON may be cut or removed as part of the procedure.
2. Consent from the operating surgeon to remove the OB of the corresponding ON in the event it is cut during the operation
3. Consent from the patient for removal of the OB of the corresponding ON in the event it is cut during the operation
Exclusion Criteria
2. Damage to anterior skull base including OBs
3. Meningitis
And applicable to group 2 only:
Patients unable to consent for surgery
18 Years
ALL
No
Sponsors
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St George's, University of London
OTHER
Responsible Party
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Principal Investigators
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Marios Papadopoulos, FRCS (SN)
Role: PRINCIPAL_INVESTIGATOR
St George's, University of London
Samira Saadoun, PhD
Role: PRINCIPAL_INVESTIGATOR
St George's, University of London
Locations
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St George's Hospital
London, Tooting, United Kingdom
Countries
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Central Contacts
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References
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Tabakow P, Jarmundowicz W, Czapiga B, Fortuna W, Miedzybrodzki R, Czyz M, Huber J, Szarek D, Okurowski S, Szewczyk P, Gorski A, Raisman G. Transplantation of autologous olfactory ensheathing cells in complete human spinal cord injury. Cell Transplant. 2013;22(9):1591-612. doi: 10.3727/096368912X663532.
Miedzybrodzki R, Tabakow P, Fortuna W, Czapiga B, Jarmundowicz W. The olfactory bulb and olfactory mucosa obtained from human cadaver donors as a source of olfactory ensheathing cells. Glia. 2006 Nov 1;54(6):557-65. doi: 10.1002/glia.20395.
Raisman G. Olfactory ensheathing cells and repair of brain and spinal cord injuries. Cloning Stem Cells. 2004;6(4):364-8. doi: 10.1089/clo.2004.6.364.
Li Y, Decherchi P, Raisman G. Transplantation of olfactory ensheathing cells into spinal cord lesions restores breathing and climbing. J Neurosci. 2003 Feb 1;23(3):727-31. doi: 10.1523/JNEUROSCI.23-03-00727.2003.
Keyvan-Fouladi N, Li Y, Raisman G. How do transplanted olfactory ensheathing cells restore function? Brain Res Brain Res Rev. 2002 Oct;40(1-3):325-7. doi: 10.1016/s0165-0173(02)00215-1.
Raisman G. Olfactory ensheathing cells - another miracle cure for spinal cord injury? Nat Rev Neurosci. 2001 May;2(5):369-75. doi: 10.1038/35072576.
Study Documents
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Document Type: Individual Participant Data Set
The project documents will be available directly from the research team. Please e-mail Dr Florence Hogg [email protected]
View DocumentOther Identifiers
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16.0069
Identifier Type: -
Identifier Source: org_study_id
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