A Phase 1/2 interventional study of ADRC injection and ADRC001 injection in Anal Fistula, sponsored by University of Southern Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by University of Southern Denmark · Phase 1/2, Interventional, and Treatment
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. The first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. The rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (ADRC Adipose-Derived Regeneative Cells) or donated cultured regenerative cells (ADRC001). All included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.
Adult patients (>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:
Exclusion criteria:
Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.
Drug: ADRC injection
Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million cultured allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.
Drug: ADRC001 injection
Allocated patients will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.
Also known as: Liposuction, Surgical debridement of fistula tract and closure of internal orifice, Injection of lipoaspirate
Allocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.
Also known as: Liposuction, Surgical debridement of fistula tract and closure of internal orifice, Injection of lipoaspirate
Healing rate (percentage)
Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
Time frame: at 6 and 12 months follow-up
QoL
functional outcome regarding quality of life, measured by Short Form SF-36 Rand questionnaire.
Time frame: at12 months follow-up.
Fecal Incontinence
functional outcome regarding fecal incontinence, measured by Wexner Fecal Incontinence score.
Time frame: at12 months follow-up.
Risk factors for recurrence of fistula.
Risk factors for recurrence of fistula including demography, prevoius surgery for fistula, disease duration and treatment arm.
Time frame: at12 months follow-up.
Radiological healing.
Radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.
Time frame: at12 months follow-up.
Treatment efficacy.
comparison of the healing rate of the fistula between patients receiving ADRC and patients receiving ADRC001 (autologous vs. allogenic cells)
Time frame: at12 months follow-up.
Cellular composition
Definition of the cellular compisition of the ADRC and ADRC001 regarding cellular surface markers (CD14, CD31, CD34, CD45, CD73, CD90, CD105, CD235a, HLA-ABC og HLA-DR) using flowcytometry.
Time frame: at 3 months follow-up.
Transplantation-related alloantibodies
Registration of the number of patients developing serum alloantibodies specific to donor genotypes, by assessment of anti-HLA (class I and II).
Time frame: at12 months follow-up.
Plan to share: No
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University of Southern Denmark