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Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold

Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Maxillary Cyst, Bone Loss of Substance

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Trial Information

Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold

The objective of this project is to provide a competitive clinical solution with an
autologous product, a balanced cost and the possibility of extending use to other

This protocol includes treatment of 10 patients with cystic disease of the jaws that meet
all the inclusion criteria and none of the exclusion criteria.

For autologous cell preparation a sample of spongy bone from the maxillary tuberosity and 20
ml of serum are obtained from the patient in order to prepare the crosslinked protein matrix
and the MSV-H cells. Cells are selected and expanded under GMP conditions according to the
methodology used in previous trials (EudraCT 2005-005498-36, 2008-001191-68 and
2009-0170450-11 ). MSV-H cells are obtained directly from biopsy culture jawbone of the
patient by cultivation techniques "in vitro" and differentiate for 21 days once conveyed in
the matrix with osteogenic differentiation medium of the following composition: DMEM, 10%
FBS, 1% P / E, 0.1 mM dexamethasone, 50 mM ascorbate 2-phosphate, 10 mM phosphate ßGlicerol.
All differentiation factors have already been approved for clinical use. After the period of
the product differentiation can be implanted to the patient.

The bioimplant is used to refill the bone defects after osteotomy and maxillary cyst
enucleation, with 5-10 million cells per unit of 2 cm in diameter and 0.3 cm thick. The
cavity is closed with the mucoperiosteal flap and sutured with reabsorbable material. The
end point of the trial is to evaluate the feasibility, safety and indications of treatment
efficacy according to both clinical criteria and objective imaging confirming the volumetric
bone regeneration and maintenance over time. For this purposes orthopantomography
exploration will be performed before and 2 and 6 months after intervention.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the feasibility and safety of the implementation of MSV in the treatment of maxillary cysts

Outcome Description:

Clinical review and orthopantomograpy at different periods (0, 2 weeks, 2 months and 6 months) assessing evolution from baseline and possible complications.

Outcome Time Frame:

up to 6 months

Safety Issue:


Principal Investigator

Luis M Redondo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

April 2011

Completion Date:

December 2013

Related Keywords:

  • Maxillary Cyst
  • Bone Loss of Substance
  • Maxillary bone cysts
  • Cell therapy
  • Mesenchymal stem cells
  • Autologous serum scaffold
  • Cysts