Reconstruction of Jaw Bone Using Mesenchymal Stem Cells

NCT02751125 | Completed Phase 1 DMC

• 1 other identifier: 2012-003139-50
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study is aimed to reconstruct atrophied posterior alveolar mandibular ridges using biomaterial and autologous bone marrow derived stem cells (BMMSC) and to insert an implant into the new bone in a prosthetically guided position.

Conditions

Bone Atrophy

Keywords

Mesenchymal stem cells; bone augmentation; bone regeneration

Outcome Measures

Primary Outcomes (1)

• Amount of newly formed bone induced by MSCs and the bone substitute. These measurements are based on radiological assessments.

  CBCT

  Four to six months post augmentation

Secondary Outcomes (2)

• Implant stability

  12 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  5 years

Study Arms (1)

Augmentation of new alveolar bone

EXPERIMENTAL

Augmentation of atrophied alveolar ridge with mesenchymal stem cells( MSC) and bis calcium phosphate(BCP)

Drug: BCP with autologous mesenchymal stem cells (MSC).

Interventions

BCP with autologous mesenchymal stem cells (MSC). DRUG

Augmentation of narrow alveolar ridge with BCP and MSC

Also known as: MSC and BCP

Augmentation of new alveolar bone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with lateral or vertical bone loss (focusing lateral bone loss) of the mandible behind the canine tooth.
• Lateral (width 5 mm or less) bone loss preventing the insertion of an implant without prior bone augmentation.
• Endentate for more than 6 months in the region requiring reconstruction.
• Endentate concerning at least 2 missing teeth in the region requiring reconstruction.
• Absence of clinical signs of infection in the region requiring reconstruction.
• Patients presenting with good dental hygiene (subjective criteria)
• Patients not presenting with any major oral pathologies.
• Dental crest size less than 5 mm.
• General criteria:
• Adult patients over 18 and under 80 years of age.
• Patients in good general health presenting with a complete blood count and renal and hepatic function values within normal limits (confirmed by local laboratory tests).
• Patients with the capacity to understand medical information and give their informed consent.

You may not qualify if:

• ocal criteria:
• Patients presenting with clinical or radiological signs of bone infection (acute or chronic osteomyelitis).
• Residual dentition close to the area requiring reconstruction with untreated endodontic disorder (apical granuloma or apical cyst).
• Untreated oral infection (cellulitis, periodontitis).
• Patients with poor hygiene (subjective criteria).
• Surgical procedure undertaken in the area requiring reconstruction less than 6 months prior to the bone graft.
• History of malignant tumors of the upper airways / digestive tract or of the jaw.
• History of or scheduled cervico-facial radiation therapy.
• General criteria:
• The patient suffers from any serious coagulation disorders that could require substitution therapy
• The patient is receiving VKA therapy, which should be adjusted if necessary so that the INR does not exceed 2.5
• The patient has history of allergy to iodine or to local anesthetics(sulfites, etc.)., or a history of hematoma, or hemorrhage or blood coagulation disorders
• The patient has received localized iliac crest radiotherapy contraindicating withdrawal from the irradiated site
• The patient has major skin lesions or diseases.
• Patients presenting with bone metabolism disorders: hypophosphatemia, primary parathyroid osteitis or that is secondary to chronic renal insufficiency or osteomalacia, Paget's disease, vitamin D-related disorders, osteoporosis.

Sponsors & Collaborators

• University of Bergen: lead
• University of Ulm: collaborator
• Haukeland University Hospital: collaborator
• Université de Nantes: collaborator

Study Sites (1)

Institute of Clinical Dentistry, University of Bergen

Bergen, Hordaland, 5008, Norway

Location

Related Publications (1)

• Gjerde C, Mustafa K, Hellem S, Rojewski M, Gjengedal H, Yassin MA, Feng X, Skaale S, Berge T, Rosen A, Shi XQ, Ahmed AB, Gjertsen BT, Schrezenmeier H, Layrolle P. Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial. Stem Cell Res Ther. 2018 Aug 9;9(1):213. doi: 10.1186/s13287-018-0951-9.

  PMID: 30092840 RESULT

Study Officials

• Cecilie Gjerde, DDS

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosiate Professor

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 26, 2016
• Study Start: June 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

NO (1)