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Study to assess the safety and efficacy of multipotent mesenchymal stem cells administration as a treatment for patients with faecal incontinence.
EU CTIS ID: 2024-515766-13-00
What this study is testing
To evaluate the safety and efficacy, as well as to determine the best regenerative treatment dose with allogeneic adult mesenchymal stem cells from adipose tissue (AMSCs), conditioned in a hyaluronic acid matrix, administered intralesionally in patients with faecal incontinence.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-80 years (both inclusive), male or female.
- 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.
- 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.
- Duration of fecal incontinence for at least 1 year prior to inclusion.
- Informed consent obtained in writing.
- 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.
You likely can't join if
- Have been previously treated with: • Perianal 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.
- Chemotherapy during the 6 months prior to the time of inclusion.
- Prior radiation with evidence of radiation injury to the area to be treated.
- 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.
- 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).
- 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.
See the full eligibility criteria
Who can join
- Age 18-80 years (both inclusive), male or female.
- 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.
- 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.
- Duration of fecal incontinence for at least 1 year prior to inclusion.
- Informed consent obtained in writing.
- 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.
What rules you out
- Have been previously treated with: • Perianal 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.
- Chemotherapy during the 6 months prior to the time of inclusion.
- Prior radiation with evidence of radiation injury to the area to be treated.
- 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.
- 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).
- 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.
- Patients with active infection by virus B, virus C or syphilis
- Patients who require a surgical procedure related to the sphincter apparatus at the time of inclusion
- 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.
- Anorectal tumors at the time of inclusion.
- Patients with active perianal diseases at the time of inclusion: fissure, fistula, venereal disease and abscess.
- Anorectal stenosis, which prevents the performance of ultrasound.
- Significant chronic anorectal or pelvic pain (moderate to severe pain according to VAS scale)
- Pregnant women or in the 6 months postpartum.
- Medical history of Human Immunodeficiency Virus (HIV) infection or any severe immunocompromised state or administration of immunosuppressive therapy.
- 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.
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.