Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)

NCT01389661 | Completed Phase 1 DMC

• 4 other identifiers: TerCel00022010-024246-30EC10-255BIOMAX-VA-2010
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Maxillary Cyst; Bone Loss of Substance

Keywords

Maxillary bone cysts; Cell therapy; Mesenchymal stem cells; Autologous serum scaffold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Indication of efficacy

  up to 6 months

Study Arms (1)

MSV treatment

EXPERIMENTAL

MSV treatment: Mesenchymal stem cells from bone marrow expanded by GMP-compliant procedure in IBGM cell production unit in autologous plasma scaffold and implanted in maxillary bone cavities after cyst removal

Biological: MSV treatment

Interventions

MSV treatment BIOLOGICAL

Autologous maxillary bone marrow mesenchymal stem cells (MSV-H) collected from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV)

Also known as: H-MSV, Human Mesenchymal Stem Cells from Valladolid

MSV treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Red de Terapia Celular: lead
• Sanidad de Castilla y León: collaborator
• University of Valladolid: collaborator
• Centro en Red de Medicina Regenerativa de Castilla y Leon: collaborator
• Citospin: collaborator

Study Sites (3)

Río Hortega University Hospital

Valladolid, Valladid, 47012, Spain

Location

Bionand, Parque Tecnológico de Andalucía, Universidad de Málaga

Málaga, Spain

Location

Instituto de Biologia y Genetica Molecular

Valladolid, 47003, Spain

Location

Related Publications (1)

• Redondo LM, Garcia V, Peral B, Verrier A, Becerra J, Sanchez A, Garcia-Sancho J. Repair of maxillary cystic bone defects with mesenchymal stem cells seeded on a cross-linked serum scaffold. J Craniomaxillofac Surg. 2018 Feb;46(2):222-229. doi: 10.1016/j.jcms.2017.11.004. Epub 2017 Nov 16.

  PMID: 29229365 DERIVED

Related Links

• Spanish Cell Therapy Network
• Cell production, Instituto de Biologia y Genetica Molecular (IBGM) University of Valladolid
• Diseases, Jaw; Jaw Disease

Study Officials

• Luis M Redondo, MD, PhD

  Oral and Maxillofacial Surgeon, Río Hortega University Hospital, SACYL, Valladolid, Spain

  PRINCIPAL INVESTIGATOR

• Ana Sánchez, MD, PhD

  Instituto de Biología y Genética Molecular (IBGM), University of Valladolid, Spain

  STUDY DIRECTOR

• Javier García-Sancho, MD, PhD

  University of Valladolid, Spain

  STUDY DIRECTOR

• Jose Becerra, PhD

  Centro Andaluz de Nanomedicina y Biotecnología (BIONAND), Universidad de Málaga, Ciber-bbn. Málaga, Spain.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MSV-H autologous transplantation: Mesenchymal stem cells from bone marrow expanded by GMP-compliant procedure in IBGM cell production unit in autologous plasma scaffold and implanted in maxillary bone cavities after cyst removal

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 8, 2011
• Study Start: April 1, 2011
• Primary Completion: April 25, 2016
• Study Completion: April 25, 2016
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

ES (3)