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Trial record 10 of 132 for:    autologous mesenchymal stem cells | Completed Studies

Study, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence

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ClinicalTrials.gov Identifier: NCT02292628
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Brief Summary:
This is a clinical trial phase I/II, double blind, randomized to compare in two groups of patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from the adipose tissue (CMMAd) in the treatment of the faecal incontinence.

Condition or disease Intervention/treatment Phase
Faecal Incontinence Drug: Infusion of mesenchymal stem cells from adipose tissue Other: Infusion of placebo Phase 1 Phase 2

Detailed Description:
In the phase of recruitment, of 20 months of duration, there will be included 16 participants who will be randomized to one of the groups of intervention (8 patients group CMMAd / 8 patients group placebo). The phase of follow-up of every patient will be 12 months, though, provided that these patients are seen regularly in the study sites of the study, once concluded his follow-up will be continued to be able to obtain safety information and efficacy to 24 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study Phase I/II, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence
Study Start Date : October 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Mesenchymal stem cells
Autologous mesenchymal stem cells from the adipose tissue in an unique intralesional infusion with a dose of 40 million cells.
Drug: Infusion of mesenchymal stem cells from adipose tissue
Placebo Comparator: Ringer lactate solution
Ringer lactate solution
Other: Infusion of placebo



Primary Outcome Measures :
  1. Number of Serious Adverse Events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Changes in the faecal incontinence diary [ Time Frame: 12 months ]
  2. Anorectal manometry [ Time Frame: 12 months ]
  3. Jorge-Wexner Score [ Time Frame: 12 months ]
  4. Faecal Incontinence Quality of Life [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females in the age group of 18-80 yrs.
  2. A unique internal sphincter defect and / or external (no more than 100 º), at any level of the anal canal, of any cause (except those described in the exclusion criteria).
  3. Severity of faecal incontinence of 12 or more in the Wexner Score and / or at least six episodes of faecal incontinence for a period of 28 days.
  4. Duration of faecal incontinence of at least two years prior to inclusion.
  5. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent.

Exclusion Criteria:

  1. More of an external sphincter defect and / or at any level of internal anal canal.
  2. Have received treatment to faecal failure with bulking agents, neuromodulation or surgery.
  3. Current anorectal tumors.
  4. Current anal fissures.
  5. Anorectal stenosis
  6. Chronic pelvic or anorectal pain.
  7. Pregnant or 6 months postpartum.
  8. Medical history of infection with Human Immunodeficiency Virus (HIV) or any severe immunocompromised state or therapy immunosuppressive.
  9. Malignancies in remission for less than a year before the study. An exception to the basocellular carcinoma (BCC) in "remission" for less than a year.
  10. Bleeding diathesis or current anticoagulant therapy.
  11. Chemotherapy during the 6 months preceding the study.
  12. Previous radiation with evidence of radiation injury in the treated area.
  13. Participation in any other clinical study during the 3 months preceding the pre-study visit.
  14. Patients with other serious disorders.
  15. Patients with uncontrolled inflammatory disease or taking drugs prohibited in the protocol or active perianal disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292628


Locations
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Spain
H. Juan Ramón Jiménez
Huelva, Spain, 21005
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Regional U de Málaga
Málaga, Spain, 29010
Hospital U Virgen del Rocio
Sevilla, Spain, 41013
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas
Investigators
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Principal Investigator: Fernando de la Portilla, Dr. Hospital U. Virgen del Rocio
Principal Investigator: Santiago Mera, Dr. Hospital Regional U de Málaga

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Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02292628     History of Changes
Other Study ID Numbers: CMMAd/InFe/2011
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases