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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01389661 |
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Date of registration:
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05/07/2011 |
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Primary sponsor: |
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Public title:
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Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)
BIOMAX |
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Scientific title:
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Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01389661 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Spain
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Contacts
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Name:
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Luis M Redondo, MD, PhD, PI |
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Address:
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Telephone:
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0034 983 233850 |
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Email:
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med020120@gmail.com |
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Affiliation:
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Name:
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Ana Sánchez, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto de Biología y Genética Molecular (IBGM), University of Valladolid, Spain |
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Name:
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Luis M Redondo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oral and Maxillofacial Surgeon, Río Hortega University Hospital, SACYL, Valladolid, Spain |
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Name:
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Javier García-Sancho, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Valladolid, Spain |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Maxillar bone cyst with diameter larger than 2 cm and smaller than 4 cm
- Understanding and written acceptance of assay conditions
- Informed written consent of the patient for assay and for surgery
- In women, negative pregnancy test at t=0
- In women, compromise of using anticonceptive methods during the study
Exclusion Criteria:
- Age under 18 or over 65
- Incapacity or legal dependence
- Pregnancy, lactancy, or enrollment in fertility programs
- Previous or concomitant oncological processes.
- Positive serology for HIV-1 orHIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab) or Hepatitis C
(Anti-HCV-Ab).
- Immunocompromised patients
- Systemic disease with potential effects on bone metabolism
- Congenital or acquired maxillofacial malformation
- Patients with prescription of drugs acting on bone metabolism, suc as glucocorticoids
and bisphosphonates
- Active or recent infection of the cyst
- Recidive of the cyst (previous surgery)
- Participation in other trials or studies in the last 3 months.
- Other pathologic conditions or circumstances that difficult participation in the
study according to medical criteria
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bone Loss of Substance
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Maxillary Cyst
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Intervention(s)
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Other: Autologous Mesenchymal Stem Cells
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Primary Outcome(s)
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To evaluate the feasibility and safety of the implementation of MSV in the treatment of maxillary cysts
[Time Frame: up to 6 months]
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Secondary Outcome(s)
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Indication of efficacy
[Time Frame: up to 6 months]
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Secondary ID(s)
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2010-024246-30
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BIOMAX-VA-2010
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EC10-255
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TerCel0002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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