Reconstruction of Jaw Bone Using Mesenchymal Stem Cells

NCT ID: NCT02751125

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2020-03-01

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.

Detailed Description

Eleven patients presenting with the need of an implant retained restoration in the posterior mandibula and an alveolar ridge of maximum 4.5 mm width.

A clinical examination, x- rays and Cone Beam CT(CBCT) are accessed. A sample of the patients' bone marrow is extracted from the posterior alveolar ridge, immediately shipped to the collaborating good clinical practice (GCP) cell laboratory for cell expansion, and returned after 21 days. The stem cells mixed with Bi Calcium Phosphate (BCP) are then used to augment the alveolar ridge. The material is covered with a titanium reinforced membrane before closure of the site. After four to six months a bone biopsy is performed and implants are installed in the regenerated bone.

The patient will be followed after 1, 2, 3, and 5 years where implant stability will be assessed. Furthermore the new formed bone will be clinically and radiologically assessed at the same time.

Conditions

Bone Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Augmentation of new alveolar bone

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

Group Type: EXPERIMENTAL

BCP with autologous mesenchymal stem cells (MSC).

Intervention Type: DRUG

Augmentation of narrow alveolar ridge with BCP and MSC

Interventions

BCP with autologous mesenchymal stem cells (MSC).

Augmentation of narrow alveolar ridge with BCP and MSC

Intervention Type: DRUG

Other Intervention Names

MSC and BCP

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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.
• Pregnant or breastfeeding women or women not using effective contraception if they are of childbearing age.
• Patients presenting with cancerous disorders (carcinoma, sarcoma, leukemia, lymphoma) or psychiatric disorders or with uncontrolled systemic diseases (diabetes, hypertension), or chronic renal disease.
• Severe bruxism.
• History of chemotherapy.
• Smoking or alcohol addiction. Occasional consumption of alcohol and/or smoking will be noted in the case report form.
• Patients with an ASA score of 0 or 1, incapable of tolerating general anesthesia.
• Immunosuppression
• Body mass index outside the normal range, particularly >30 because of increased surgical risk at the time of BM harvesting from the iliac crest.
• Risk of remote infection (orthopedic prosthesis implanted in the previous 6 months, patients presenting with a high risk of infective endocarditis, presence of pulmonary arteriovenous shunt, etc.).
• HIV, HTLV and/or syphilis seropositivity.
• Hepatitis B or C infection.
• Active autoimmune disease.
• History of immunosuppressant treatment or bone marrow treatment.
• Administration of treatment interfering with bone metabolism.
• Patients requiring antibiotic prophylaxis before any dental procedure
• Patients reticent to undergo dental care or periodontal treatment
• Concomitant treatments: history of treatment or current treatment with bisphosphonates, long term corticosteroid treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Université de Nantes

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Cecilie Gjerde

Assosiate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecilie Gjerde, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

Institute of Clinical Dentistry, University of Bergen

Bergen, Hordaland, Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 30092840 (View on PubMed)

Other Identifiers

2012-003139-50

Identifier Type: -

Identifier Source: org_study_id