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Allogeneic Dental Pulp Stem Cells for the Treatment of Periodontitis

Clinical Study of Allogeneic Dental Pulp Stem Cells for the Treatment of Periodontitis

The overall objective of this study is to evaluate the safety and efficacy of allogeneic human dental pulp stem cells (DPSCs) injected for the treatment of chronic periodontitis in humans. It aims to develop a stem cell injection therapy that promotes the regeneration of periodontal soft and hard tissues through a non-invasive (minimally invasive) procedure, thereby replacing traditional traumatic periodontal surgery.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

Periodontitis, a chronic inflammatory disease, affects over 700 million people worldwide, leading to bone and soft tissue destruction as well as systemic inflammatory manifestations. For severe periodontitis, current treatments mainly rely on invasive surgical procedures such as guided tissue regeneration, combined with bone grafting and growth factors. However, such surgeries often cause significant pain and discomfort to patients, and tissue regeneration is frequently incomplete, with risks of infection and uncontrolled tissue growth.

As a type of mesenchymal stem cell, dental pulp stem cells (DPSCs) can be easily obtained through a non-invasive procedure from orthodontically extracted or removed wisdom teeth. Compared to bone marrow- or adipose-derived stem cells, DPSCs exhibit stronger proliferative capacity and are better able to resist oxidative stress and cellular senescence within the periodontitis microenvironment. DPSCs have low immunogenicity and can interact with T cells, B cells, natural killer cells, macrophages, and others. For example, they can induce T cell anergy by secreting relevant factors, or regulate the proliferation and differentiation of B cells, thereby reducing the risk of immune rejection after allogeneic transplantation.

In light of the above research status, the conduct of this study holds the following outstanding value at both the scientific exploration and clinical application levels: Currently, most studies on stem cell therapy for periodontitis still rely on traditional flap surgery for transplantation. The DPSC injection therapy focused on in this study pioneeringly achieves the promotion of periodontal soft and hard tissue regeneration through simple local injection (e.g., intra-periodontal pocket injection). This not only greatly improves patient comfort but also provides a more convenient and minimally invasive treatment option for patients with severe periodontitis who would otherwise require complex periodontal surgery. The pathogenic mechanism of periodontitis is complex, with the core being the disruption of local microenvironmental homeostasis. Exogenous DPSC injection not only acts as "seed cells" for tissue regeneration but also, through paracrine secretion of various cytokines, remodels the immune microenvironment, restores local homeostasis, and thus achieves the "dual benefit" of reducing periodontal pocket depth and repairing alveolar bone defects. Investigating its specific molecular targets and regulatory pathways holds high scientific value. Considering that DPSCs are abundantly available, easily scalable for expansion, and have extremely low immunogenicity, they possess great potential as "off-the-shelf" allogeneic stem cell drugs. Compared to maxillofacial tissue reconstruction surgeries using recombinant growth factors, the minimally invasive stem cell injection strategy not only has a lower technical barrier but also offers significant advantages in time cost and economic efficiency, effectively reducing the healthcare burden.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Disease Diagnosis: Clinically diagnosed with chronic periodontitis (typically Stage III or IV according to the latest periodontal disease classification).
  • Target Tooth Requirements: At least two non-adjacent periodontal pockets with a Probing Pocket Depth (PPD) ≥5 mm.
  • Clinical Attachment Level (CAL) loss ≥3 mm.
  • Evidence of significant alveolar bone resorption on X-ray or CBCT (bone loss exceeding one-third of the root length).
  • Age and General Condition: Typically aged 18-70 years, in good general health, and able to complete the 12-month follow-up.
  • Oral Hygiene Awareness: Subjects are willing to receive conventional periodontal basic treatment (SRP) and demonstrate a good willingness to maintain oral hygiene (e.g., plaque index controlled at a low level).

Exclusion Criteria:

  • Systemic Diseases: Presence of severe, uncontrolled systemic diseases (e.g., diabetes with HbA1c >7%, active hepatitis, tuberculosis). History of malignancy or immunodeficiency diseases (due to the proliferative potential of stem cells, cancer risk must be strictly excluded).
  • Local Interfering Factors: Target teeth with severe mobility (Grade III mobility) or non-restorable residual crowns/roots. Received periodontal surgical treatment or systemic antibiotics within the past 3 months.
  • Special Populations and Habits: Heavy smokers (typically defined as smoking >10 cigarettes per day), as smoking significantly inhibits the regenerative effect of stem cells and local blood supply. Pregnant or breastfeeding women. Individuals allergic to any components of the study preparation (e.g., specific biological carriers).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Allogeneic Dental Pulp Stem Cells
The overall objective of this study is to evaluate the safety and efficacy of allogeneic human dental pulp stem cells (DPSCs) injected for the treatment of chronic periodontitis in humans. It aims to develop a stem cell injection therapy that promotes the regeneration of periodontal soft and hard tissues through a non-invasive (minimally invasive) procedure, thereby replacing traditional traumatic periodontal surgery.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Probing Pocket Depth (PPD)
Tidsram: Up to 12 month
The distance from the bottom of the periodontal pocket to the gingival margin is measured using a standardized periodontal probe.
Up to 12 month

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Alveolar Bone Regeneration Height (Alveolar Bone Level):
Tidsram: Up to 12 month
Cone beam computed tomography (CBCT) scanning is used to quantitatively calculate the increase in bone height and changes in bone density in the vertical bone resorption area.
Up to 12 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Wenjie Ren, The First Affiliated Hospital of Xinxiang Medical College

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 april 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2028

Studieregistreringsdatum

Först inskickad

9 april 2026

Först inskickad som uppfyllde QC-kriterierna

3 maj 2026

Första postat (Faktisk)

8 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • ADPSC-2026-01

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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