Bone AtrophyPhase 1NCT02751125
Reconstruction of Jaw Bone Using Mesenchymal Stem Cells
A Phase 1 study testing BCP with autologous mesenchymal stem cells (MSC). in people with Bone Atrophy, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Atrophy
- What is being tested?
- BCP with autologous mesenchymal stem cells (MSC).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2014to 1 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Institute of Clinical Dentistry, University of Bergen
Bergen, Hordaland, 5008
About this study
Official title: Jaw Bone Reconstruction Using a Combination of Autologous Mesenchymal Stem Cells and Biomaterial Prior to Dental Implant Placement
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.
Read the 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
- Being tested
- BCP with autologous mesenchymal stem cells (MSC).
- Keywords
- Mesenchymal stem cells, bone augmentation, bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCP with autologous mesenchymal stem cells (MSC).Drug
Also called MSC and BCP
Augmentation of narrow alveolar ridge with BCP and MSC
| Study group | Role | What they receive |
|---|---|---|
| Augmentation of new alveolar bone | Experimental | Augmentation of atrophied alveolar ridge with mesenchymal stem cells( MSC) and bis calcium phosphate(BCP) Receives: Drug: BCP with autologous mesenchymal stem cells (MSC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of newly formed bone induced by MSCs and the bone substitute. These measurements are based on radiological assessments.
CBCT
Measured: Four to six months post augmentation
Secondary outcomes (2)
Implant stability
Implant stability measurement using the Ostell system
Measured: 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety of MSC in patients. Adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJun 2014
- Primary completion1 Mar 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm, Haukeland University Hospital, Université de Nantes
- Responsible party
- Principal investigator, Cecilie Gjerde, University of Bergen
- Investigators
- Cecilie Gjerde, DDS, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751125
- Sponsor's protocol ID
- 2012-003139-50
- Status last verified
- Mar 2020
- First submitted
- 22 Mar 2016
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 30092840
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jaw Bone Reconstruction Using a Combination of Autologous Mesenchymal Stem Cells and Biomaterial Prior to Dental Implant Placement
- ClinicalTrials.gov ID
- NCT02751125
- Acronym / sponsor ID
- 2012-003139-50
- Conditions
- Bone Atrophy
- Keywords
- Mesenchymal stem cells, bone augmentation, bone regeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- University of Ulm, Haukeland University Hospital, Université de Nantes
- Study start
- Jun 2014 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmentation of new alveolar bone | Experimental | Drug: BCP with autologous mesenchymal stem cells (MSC).Augmentation of atrophied alveolar ridge with mesenchymal stem cells( MSC) and bis calcium phosphate(BCP) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCP with autologous mesenchymal stem cells (MSC).Also: MSC and BCPAugmentation of narrow alveolar ridge with BCP and MSC | Drug | Augmentation of new alveolar bone |
Primary outcome
Amount of newly formed bone induced by MSCs and the bone substitute. These measurements are based on radiological assessments.
Time frame: Four to six months post augmentation
CBCT
2 secondary outcomes
Implant stability
Time frame: 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Results publication: PubMed 30092840Gjerde 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.
- Individual participant dataSharing planned: Undecided
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Enrolling by invitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilie Gjerde, DDS principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCP with autologous mesenchymal stem cells (MSC). in people with Bone Atrophy, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of newly formed bone induced by MSCs and the bone substitute. These measurements are based on radiological assessments. (time frame: Four to six months post augmentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.