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Chronic Periodontal DiseasePhase 1/2BMMSCNCT05975892

Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

A Phase 1/2 study testing Transplantation of allogeneic MSCs in periodontal disease in people with Chronic Periodontal Disease and Aggressive Periodontitis, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (MSC) to induce bone regeneration in patients with periodontal disease. MSC cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Transplantation of allogeneic MSCs in periodontal disease
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteVenezuela
Study dates
30 Aug 2018to 30 Aug 2024
Phase
Phase 1/2
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Medical healthy
  • Minimum age of 18 years old
  • Diagnosis of chronic or aggressive periodontitis
  • Vertical intrabony defects of three or two walls
  • PPD >= 5 mm
  • Radiographic evidence of alveolar bone loss of at least 3 mm
  • Minimim 20 teeth presents in mouth.
  • Informed consent of the patient

Who cannot join

  • Smoking
  • Pregnancy or lactating
  • Receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs
  • Diabetics

Trial locations and contacts

1 site in 1 country.

Venezuela1 site

  • Instituto Venezolano de Investigaciones Cientificas

    Caracas, Miranda, 1204

Other trials in Venezuela

About this study

Official title: Transplantation of Bone Marrow Mesenchymal Stromal Cells for Bone Regeneration in Periodontal Disease

The goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (MSC) to induce bone regeneration in patients with periodontal disease. MSC cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect.

Read the detailed description

The clinical protocol is designed to evaluate the bone regeneration capacity of allogeneic MSCs for the treatment of patients with chronic or aggressive periodontal disease. Patients with either a 2- or 3-wall intrabony defects are included in this study. A bioengineering construct, constituted by allogeneic MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, which is implanted at the bone defect site. Follow up of treated tooth are assessed by clinical evaluation, intraoral radiography and cone-beam CT.

Being tested
Transplantation of allogeneic MSCs in periodontal disease
Keywords
Mesenchymal stromal cells, Periodontal regeneration, Bone regeneration, Periodontitis
Medical subject headings
Chronic Periodontitis, Aggressive Periodontitis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transplantation of allogeneic MSCs in periodontal diseaseBiological

    Oral surgery is performed in patients with periodontal disease, under local anesthesia. An incision will be made on the periodontal lesion, A full-thickness flap is elevated on both the buccal and lingual areas and the inner epithelium of the flap removed. Granulation tissue is removed from bone defect area, and a root planning is performed. MSC construct is placed around the bone defect and a collagen membrane is used to cover and close off the bone defect site. The flap will be repositioned and the wound closed by a suture

Study groups in NCT05975892
Study groupRoleWhat they receive
Allogeneic MSCs transplantation in periodontal diseaseExperimentalAllogeneic MSC harvested and cultured in osteogenic medium are seeded on collagen scaffold, mixed with autologous platelet rich plasma clot. The MSCs construct (MSCs/Coll/PRP clot) is implanted in the bone defect.
Receives: Biological: Transplantation of allogeneic MSCs in periodontal disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in clinical attachment level (CAL)

    Expressed as the distance in millimeters from the cemento-enamel junction (CEJ) to the bottom of the probable gingival/periodontal pocket.

    Measured: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

  2. Change in probing pocket depth (PPD)

    The distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured by means of periodontal probe.

    Measured: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

  3. Gingival recession (GR)

    Exposure of the tooth through apical migration of the gingiva will be recorded as the distance in millimeters from the CEJ to the gingival margin

    Measured: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

  4. Change in bone density

    Changes in the density of the periodontal bone defect will be detected by Cone beam Tomography

    Measured: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

  5. Change in Tooth Mobility (TM)

    Changes from baseline in tooth mobility will be recorded.

    Measured: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

  6. Change in bone depth

    The vertical bone defects will be assessed by X-rays. The postoperative depth of the intrabony defect will be calculated from the distance between the cemento-enamel junction and the bone crest on the preoperative and postoperative radiographs at the same magnification.

    Measured: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start30 Aug 2018
  3. Primary completion30 Aug 2022
  4. Study completion30 Aug 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05975892
Sponsor's protocol ID
IVIC-UTC-MSC-Periodontal
Acronym
BMMSC
Status last verified
Jul 2023
First submitted
14 Jul 2023
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wittig O, Diaz-Solano D, Cardier J. Viability and functionality of mesenchymal stromal cells loaded on collagen microspheres and incorporated into plasma clots for orthopaedic application: Effect of storage conditions. Injury. 2018 Jun;49(6):1052-1057. doi: 10.1016/j.injury.2018.04.005. Epub 2018 Apr 5.

    PubMed 29678307

  • Wittig O, Romano E, Gonzalez C, Diaz-Solano D, Marquez ME, Tovar P, Aoun R, Cardier JE. A method of treatment for nonunion after fractures using mesenchymal stromal cells loaded on collagen microspheres and incorporated into platelet-rich plasma clots. Int Orthop. 2016 May;40(5):1033-8. doi: 10.1007/s00264-016-3130-6. Epub 2016 Mar 16.

    PubMed 26980620

  • Gomez M, Wittig O, Diaz-Solano D, Cardier JE. Mesenchymal Stromal Cell Transplantation Induces Regeneration of Large and Full-Thickness Cartilage Defect of the Temporomandibular Joint. Cartilage. 2021 Dec;13(1_suppl):1814S-1821S. doi: 10.1177/1947603520926711. Epub 2020 Jun 4.

    PubMed 32493042

  • Gomez-Sosa JF, Diaz-Solano D, Wittig O, Cardier JE. Dental Pulp Regeneration Induced by Allogenic Mesenchymal Stromal Cell Transplantation in a Mature Tooth: A Case Report. J Endod. 2022 Jun;48(6):736-740. doi: 10.1016/j.joen.2022.03.002. Epub 2022 Mar 18.

    PubMed 35307516

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Transplantation of allogeneic MSCs in periodontal disease in people with Chronic Periodontal Disease and Aggressive Periodontitis, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.

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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Aug 2023. 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 Venezuela. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Change in clinical attachment level (CAL) (time frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation). The study lists 6 primary outcomes in all. 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 NCT05975892, which also lists 4 linked publications.

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 4 Aug 2023.

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