Maxillary Cyst Clinical Trial
— BIOMAXOfficial title:
Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold
Verified date | April 2017 |
Source | Red de Terapia Celular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial pretends to validate for clinical use a bioengineered product composed of MSV cells (mesenchymal stem cells produced by IBGM, Valladolid, which have already been approved by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These two groups collaborate in the present project with the team of Maxillofacial Surgery of the Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the medical aspects. The proposed trial is based on positive results obtained in previous animal studies performed by the present multidisciplinary team. The investigators propose a phase I / II clinical trial with 10 patients suffering from bone cysts in the maxillofacial region. Autologous mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity filled with the protein matrix containing the mesenchymal cells. Checks will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and computerized tomography scan.
Status | Completed |
Enrollment | 11 |
Est. completion date | April 25, 2016 |
Est. primary completion date | April 25, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Bionand, Parque Tecnológico de Andalucía, Universidad de Málaga | Malaga | |
Spain | Instituto de Biologia y Genetica Molecular | Valladolid | |
Spain | Río Hortega University Hospital | Valladolid | Valladid |
Lead Sponsor | Collaborator |
---|---|
Red de Terapia Celular | Centro en Red de Medicina Regenerativa de Castilla y Leon, Citospin, Sanidad de Castilla y Leon (SACYL), University of Valladolid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the feasibility and safety of the implementation of MSV in the treatment of maxillary cysts | Clinical review and orthopantomograpy at different periods (0, 2 weeks, 2 months and 6 months) assessing evolution from baseline and possible complications. | up to 6 months | |
Secondary | Indication of efficacy | Imaging exploration to evaluate effectiveness through development of criteria for orthopantomography and bone-CT quantitative bone regeneration Evolution at 2 and 6 months from intervention will be assessed. | up to 6 months |
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