Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia

NCT05857358 | Not Yet Recruiting Phase 1

• 1 other identifier: 2023-505149-20-00
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (8)

• Intensity of adverse reactions at the injection site at day 1

  1 day after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment

  1 day

• Intensity of adverse reactions at the injection site at day 3

  3 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment.

  3 days

• Intensity of adverse reactions at the injection site at day 7

  7 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.

  7 days

• Intensity of adverse reactions at the injection site at day 14

  14 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.

  14 days

• Intensity of adverse reactions at the harvesting site at day 1

  1 day after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with phone assessment.

  1 day

• Intensity of adverse reactions at the harvesting site at day 3

  3 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event, through an adapted report form with phone assessment.

  3 days

• Intensity of adverse reactions at the harvesting site at day 7

  7 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event, through an adapted report form with clinical assessment.

  7 days

• Intensity of adverse reactions at the harvesting site at day 14

  14 days after ADSVF injection, a subjective evaluation will be done by the patient of pain, oedema or ecchymosis bleeding or haematoma, inflammation or infection, other event through an adapted report form with clinical assessment.

  14 days

Secondary Outcomes (16)

• Intensity of adverse reactions at the injection site at day 15

  15 days

• Intensity of adverse reactions at the injection site at month 1

  1 month

• Intensity of adverse reactions at the injection site at month 3

  3 months

• Intensity of adverse reactions at the injection site at month 6

  6 months

• Intensity of adverse reactions at the injection site at month 7

  7 months

Study Arms (1)

Adult patients suffering from xerostomia and autoimmune disease

EXPERIMENTAL

Xerostomia treatment consist of 3 steps (including 2 surgical steps) in the Hospital de la Conception of Marseille, in the same ward : * The plastic/maxillofacial surgeon : collects the adipose tissue, and transfers it to the cell therapy unit; * The cell therapy unit processes and controls the experimental product (adipose-derived stromal vascular fraction; AD-SVF) from the harvested adipose tissue. The AD-SVF batch is nominatively transported to the surgeon; * The maxillofacial surgeon injects the AD-SVF without delay under local anesthesia.

Procedure: lipoaspiration; Drug: Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)

Interventions

lipoaspiration PROCEDURE

Adipose tissue harvest will be conducted by a surgeon under under local and intra-veinous sedation anesthesia. Once the patient is asleep and just before the laying of the operating drapes, the skin will be thoroughly disinfected, in order to avoid bacteriological contamination. Each entry point will be disinfected with betadine before and regularly during the procedure and will receive local anesthesia. The lipoaspiration sites will be infiltrated using a closed system, thanks to a Khoury canula. Adipose tissue will be harvested after waiting at least 5 minutes, in order to limit hematoma and excessive blood harvesting. A 3mm incision will be made then the tissue collection will be performed using a canula, manually, by gentle aspirations into a syringe then directly transferred into a connected sterile bag. The incision will be closed with 1 stitch of 6-0 absorbable and a paraffin gauze dressing. Then, patient will be awaken and transported to the recovery room.

Adult patients suffering from xerostomia and autoimmune disease

Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF) DRUG

Autologous uncultured (AD-SVF) will be isolated by digestion and centrifugation of adipose tissue from lipoaspiration. Then, AD-SVF will be injected in 6 sites : * 2 for the accessory labial glands (0.5mL in the upper lip and 0.5mL in the lower lip) * 2 for the sublingual glands (0.5mL for each gland) * 2 for the inner face of cheeks (0.5mL for each side) The volume of injection will be of 3 mL containing 30 millions of AD-SVF viable nucleated cells for the total safety dose.

Adult patients suffering from xerostomia and autoimmune disease

Eligibility Criteria

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

You may qualify if:

• Patients from 18 to 65 years.
• Patients suffering from xerostomia and autoimmune disease including : Gougerot-Sjögren disease according to AC/EULAR criteria and Secondary Gougerot-Sjögren syndrome related to systemic diseases (sclerodermia, rheumatoid arthritis, systemic lupus erythematosus...)
• Xerostomia visual scale (6-item visual analogue scale questionnaire) for assessment of salivary dysfunction : score ≥ 30/60
• Informed consent to participate (with signature)
• Negative β -HCG test and effective contraception for women being able to get pregnant
• Affiliation to the social security system

You may not qualify if:

• Medical history of head and neck neoplasia
• Recent (\<3 months) medication inducing and aggravating xerostomia : Standard treatment with tricyclic antidepressant and/or antipsychotics
• Body Mass Index \< 18
• Active smoking (\> 5 cigarettes a day)
• Active infectious disease and/or active viral serologies (HIV, HCV, HBV, HTLV I/II, TPHA/VDRL)
• Coagulation disorders including anticoagulant and antiplatelet treatment
• Any temporary or definitive contraindication due to any medical or surgical unstable condition
• Allergy to local anesthesia and/or albumin
• Pregnant or breastfeeding women
• Adult protected by the law (tutorship and curatorship)
• Patients already enrolled in another study
• Patients under 18 years of age
• Person deprived of liberty
• Patient non-affiliated to the social security

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Laurent Guyot, Pr

CONTACT

04 91 43 63 13; Laurent.guyot@ap-hm.fr

Alexandra Giuliani

CONTACT

0491382870; alexandra.giuliani@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 12, 2023
• Study Start: January 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share