Allogeneic adipose-derived adult mesenchymal stem cells expanded for Fecal incontinence

Inclusion criteria

• {"criterion_text":"- Age 18-80 years (both inclusive), male or female.\n- A single internal and/or external sphincter defect, not more than 140 degrees, at any level of the anal canal. Therefore, the following may be included - Patients with a single external sphincter defect equal to or less than 140 degrees without or with an associated internal defect (in this case the degree of separation of the internal sphincter does not matter). - Patients with no external sphincter defect and a single internal sphincter defect equal to or less than 140 degrees.The internal defect will be used for treatment.\n- Fecal incontinence severity of 12 or more on the Wexner Test and/or at least 6 episodes of fecal incontinence over at least a 21-day period, recorded in the Patient Diary.\n- Duration of fecal incontinence for at least 1 year prior to inclusion.\n- Informed consent obtained in writing.\n- Commitment to use an effective contraceptive method, both in men and women, during the entire follow-up period of the clinical trial**. **Effective contraception for women is described as an oral contraceptive method (combining estrogens with gestagens) or another type of contraception, such as an injectable, implantable or patch hormonal contraceptive, IUD or surgical sterilization. The combined use of a condom plus a spermicidal cream is described as an effective contraceptive method for men."}

Exclusion criteria

• {"criterion_text":"- Have been previously treated with: •\tPerianal bulking agents: dextranomer in stabilized hyaluronic acid (NASHA Dx), silicone material (PTQ™), autologous fat, Teflon, bovine glutaraldehyde cross-linked collagen, carbon-coated zirconium beads, polydimethylsiloxane elastomer, polyacrylamide cross-linked hydrogel, porcine dermal collagen, synthetic calcium hydroxyapatite ceramic microspheres or polyacrylonitrile cylinders.\n- Chemotherapy during the 6 months prior to the time of inclusion.\n- Prior radiation with evidence of radiation injury to the area to be treated.\n- Participation in any other clinical study during the 3 months prior to the pre-selection visit, as well as during the execution of the trial.\n- Patients with other serious conditions, anticipated to be unreliable, or otherwise not suitable for participation in the investigator's judgment (eg, severe psychiatric illness or other illness that precludes or does not ensure adequate patient follow-up).\n- Patients with inflammatory or autoimmune disease, uncontrolled or controlled with immunosuppressants or immunomodulators. For biological antibody type treatment it will be consulted specifically the drug and the pathology with preclinical and clinical coordinators.\n- Patients with active infection by virus B, virus C or syphilis\n- Patients who require a surgical procedure related to the sphincter apparatus at the time of inclusion\n- Patients with uncontrolled diarrhea or secondary to a process diagnosed as collagenous colitis, inflammatory disease, etc., at the time of inclusion. Patients with chronic constipation who require taking laxatives at the time of inclusion.\n- Anorectal tumors at the time of inclusion.\n- Patients with active perianal diseases at the time of inclusion: fissure, fistula, venereal disease and abscess.\n- Anorectal stenosis, which prevents the performance of ultrasound.\n- Significant chronic anorectal or pelvic pain (moderate to severe pain according to VAS scale)\n- Pregnant women or in the 6 months postpartum.\n- Medical history of Human Immunodeficiency Virus (HIV) infection or any severe immunocompromised state or administration of immunosuppressive therapy.\n- Malignancies in remission for less than one year prior to study. An exception to the requirement is basal cell carcinoma (BCC). BCC in \"remission\" for less than one year is not an exclusion criterion, provided the BCC has been treated and there is no evidence of active disease.\n- Patients with a pathology or clinical condition that prevents the administration of anesthesia and the performance of the intervention in the opinion of the anesthesiologist (eg hemorrhagic diathesis, thrombocytopenia or anticoagulant therapy)."}

Primary endpoints

• {"endpoint_text":"- A) Safety variables: All clinical adverse events will be collected during follow-up at the same times as the clinical assessment. The cumulative incidence of adverse events attributed to study therapy at 12 months post-treatment will be assessed as the primary endpoint.","definition_or_measurement_approach":"All clinical adverse events collected during follow-up at the scheduled clinical assessments; cumulative incidence of adverse events attributed to study therapy assessed at 12 months post-treatment."}
• {"endpoint_text":"- B) Variables that measure clinical efficacy by assessing the severity of incontinence: Changes from baseline (pre-implantation) measurement of:","definition_or_measurement_approach":"Changes from baseline (pre-implantation) measurements of clinical efficacy variables assessing incontinence severity (see related endpoints J, number of episodes, quality of life, etc.)."}
• {"endpoint_text":"- Jorge-Wexner test score. Scales for assessing the degree of incontinence are numerous and vary in complexity. The Jorge-Wexner test provides a simple and objective assessment of both stool characteristics and frequency of incontinence episodes, where 0 represents perfect continence and 20 represents the highest degree of incontinence. It will be calculated preoperatively and when appropriate according to visits.","definition_or_measurement_approach":"Jorge-Wexner score calculated preoperatively and at scheduled visits; score range 0–20 with higher scores indicating greater incontinence."}
• {"endpoint_text":"- Number of episodes of faecal incontinence of loose or solid stools (based on data from the patient's defecation diary).","definition_or_measurement_approach":"Count of faecal incontinence episodes (loose or solid stools) recorded by the patient in the defecation diary, compared to baseline."}
• {"endpoint_text":"- Score on the faecal incontinence quality of life scale, a survey validated by the American Association of Colorectal Surgeons and recently by the Spanish Digestive Surgeons, which has been adapted and validated in its Spanish version. The 29 questions are divided into 4 different health domains: lifestyle, behaviour, depression/self-perception and embarrassment. Responses to each question are scored from 1 to 5, with 1 indicating the worst quality of life status.","definition_or_measurement_approach":"Faecal Incontinence Quality of Life scale (29 items across 4 domains), responses scored 1–5; instrument administered per schedule and compared to baseline."}
• {"endpoint_text":"- Anal manometry: Measures the anal pressure profile using a manometer. Parameters of interest (mm Hg): Maximum basal pressure, maximum voluntary contraction pressure, anal canal length, inhibitory recto-anal reflex, rectal sensitivity. It will be used to know the basal pressure state of the patient's sphincter and rectal complex, and thus be able to compare these parameters after treatment, allowing us to know if it has had any impact and where (sphincter or rectal sensitivity).","definition_or_measurement_approach":"Anal manometry measurements (mm Hg) of parameters including maximum basal pressure, maximum voluntary contraction pressure, anal canal length, inhibitory recto-anal reflex, rectal sensitivity; baseline and post-treatment comparisons."}

Secondary endpoints

• {"endpoint_text":"- A) Other clinical efficacy variables (imaging variables): 3D endorectal ultrasound: a ir prminimally invasive scan that allows ultrasound imaging of the layers of the rectal wall, anal sphincters and the organs around the rectum and anus, and allows ultrasound monitoring of lesions and theognostic evolution. It is performed according to Starck's classification. Proctoscopy: Inflammation, ulceration, normal. Rectoscopy: Inflammation, ulcer, normal.","definition_or_measurement_approach":"3D endorectal ultrasound per Starck classification; proctoscopy and rectoscopy reporting inflammation/ulceration/normal; used to monitor lesions and structural changes."}
• {"endpoint_text":"- B) Efficacy variables for analysis purposes: Changes in the use of continence-enhancing drugs: the use of continence-enhancing drugs will be collected in the CRD to assess the differences between the two groups with respect to the following parameters: 1 Number of patients reaching the clinical condition that enables withdrawal of previously prescribed continence-enhancing drugs. Time to reach this condition","definition_or_measurement_approach":"Collection in CRD of medication use; endpoint: number of patients who can stop previously prescribed continence-enhancing drugs and time to reach that condition."}
• {"endpoint_text":"- B) Efficacy variables for analysis purposes: Changes in the use of continence-enhancing drugs: the use of continence-enhancing drugs will be collected in the CRD to assess the differences between the two groups with respect to the following parameters: 2 Number of patients who need to initiate the administration of continence-enhancing drugs during follow-up, if they were not prescribed at inclusion. Time to reach this condition","definition_or_measurement_approach":"Collection in CRD of initiation of continence-enhancing drugs during follow-up for patients not on them at inclusion; endpoint: number of patients initiating treatment and time to initiation."}
• {"endpoint_text":"- C) Therapy feasibility variable: •\tIt will be collected in the CRD if the procedure of administration of the cellular product/comparator, was performed correctly, without incidences or complications, recording in the same any incidence or complication that took place.","definition_or_measurement_approach":"CRD recording of whether the administration procedure of the cellular product/comparator was performed correctly and documentation of any incidences or complications."}

Spain

Earliest CTIS Part Ii Submission Date

24-06-2024

Latest Decision Or Authorization Date

13-06-2025

Processing Time Days

354

Number Of Sites

9

Number Of Participants

68

Primary sponsor

Full Name

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain