Fecal IncontinencePhase 1/2NCT02161003
Stem Cells Therapy for Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
A Phase 1/2 study testing Stem Cells Injection Technique and Stem Cell Isolation in people with Fecal Incontinence, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The problem of the incontinence imposes considerable strain on the child and their parents. These patients suffer from a long-life handicap and they need support and follow-up. The cost associated with these diseases has clearly been illustrated to be a major component in the healthcare spending picture, may be adding… Read more about this study
- Who is it for?
- Ages 2 to 12 years, men only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Stem Cells Injection Technique and Stem Cell Isolation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male Childern Ages: above 2 Years old.
- Patient with FI. After PSARP repair of high imperforate anus.
- Absence of parasitic and infective bacterial growth after Stool analysis and stool culture.
- -
Who cannot join
- Any degree of Spinal cord injury, systemic, neuronal paralysis or sacral agenesis.
- Absence of muscle activity detected by EMG.
- Ano-rectal disorders such as tumors, fissures, anal or rectal prolapse, and rectocele.
- Positive stool culture resistant to preoperative oral antibiotic therapy.
- Previous injection of bulking agents at the level of sphincter.
- Immunocompromise patient.
- Previous adverse reaction to anesthesia.
Trial locations and contacts
1 site in 1 country.
Refaat Ibrahiem El-Badawy contact
Egypt1 site, 1 recruiting
- Recruiting
Pediatric Surgery Outpatients Clinics - Al Hussien Hospital
Madīnat an Naşr, Cairo Governorate
Contact: Abdel-Wahab El-Okby, MD, +201001478100
Refaat Ibrahiem El-Badawy, MD
About this study
Official title: Therapeutic Effect of Stem Cells in Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
The problem of the incontinence imposes considerable strain on the child and their parents. These patients suffer from a long-life handicap and they need support and follow-up. The cost associated with these diseases has clearly been illustrated to be a major component in the healthcare spending picture, may be adding hundreds of thousands of dollars to healthcare cost, as well as loss of productivity in the work force. Fecal incontinence treatment has been a difficult challenge for surgeons for several generations until now the current traditional surgical result is unsatisfactory. Mesenchymal Stem Cells injection may represent a new attractive treatment option for anal sphincter lesions. Moreover, experimental injury of muscle of anal sphincter in rats has been successfully treated with stem cells injections. In this study, the investigators will shed more light on the ability of Mesenchymal Stem Cells to induce myogenesis and regenerate anal Sphincter of patients with fecal incontinence. It will be very useful to many Egyptian patients.
Read the detailed description
A stem cell is capable of forming various tissue under definite signals received from the body. Stem cell research in animals has been an ongoing program in the west with fruitful results. Current challenges with the use of stem cells in clinical practice will be solve the many unanswered queries. To study the potential therapeutic effects of local Mesenchymal Stem cell injection in children presenting with fecal incontinence (FI) after posterior sagittal ano-rectoplasty (PSARP) operation for high imperforate anus. Children whom suffering from FI after PSARP for high imperforate anus will included in this study. Autologous MSC from the upper posterior iliac crest bone marrow sample will be extracted from patients under general anesthesia, in a suitable clean operation room. Will be Cultured and injected into the external anal sphincter defect using direct pena stimulator or ultra sound guidance. Then followed up for 180 days post injection, to assess the ability of mesenchymal stem cells to induce myogenesis of the anal Sphincter of patients with FI after PSARP.
- Conditions
- Fecal Incontinence
- Being tested
- Stem Cells Injection Technique, Stem Cell Isolation
- Keywords
- Fecal Incontinence, Posterior Sagittal Ano-rectoplasty, Mesenchymal Stem Cell
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cells Injection TechniqueProcedure or surgery
Injection of MSCs for the treatment of anal sphincter insufficiency is a potential alternative therapy for imperforate anus patients who have undergone primary PSARP with post-operative FI. In this study a single dose of 1.2 ml MSC will be divided into 12 part of 0.1ml of MSC, doses will be injected into the anal sphincter all around in 12 injection sites according to the clock meridian under general anesthesia without giving muscle relaxant.
Stem Cell IsolationProcedure or surgery
From the upper posterior iliac crest 10 ml bone marrow sample will be extracted from patients using a heparinized syringe, under general anesthesia, in a suitable clean operation room.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells Isolation | Experimental | Stem cell isolation technique and Stem Cells Injection Technique The method of isolation of MSC from bone marrow will be carried out using the Ficoll-Paque technique for the isolation of mononucleated cells followed by the separation of MSC by adherence to plastic. Finally, the cells will be resuspended and counted using a hemocytometer.
Mononucleated cells will be cultured and incubated at 37°C in an atmosphere of 95% relative humidity and 5% CO2. Receives: Procedure: Stem Cells Injection Technique; Procedure: Stem Cell Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome measures
Incontinence Score
Measured: 24 Weeks
Secondary outcomes (4)
Assessment of Clinical Parameters
This Including:
Clinical Assessment. Continence score.
Measured: 24 Weeks
Clinical Assessment
Maximum dry interval per day will be measured after injection at day 1, 30 and 90.
Measured: 12 Weeks
Clinical Assessment
MRI pelvic floor muscles study will be done after 90 days post injection.
Measured: 24 Weeks
Assessment of Urinary sphin Assessment of Urinary Sphincter (Electrophysiology Study)
EMG study will be done after 90, 180 days post injection.
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Ain Shams University, Affiliated Hospital to Academy of Military Medical Sciences, Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Sayed Bakry, Al-Azhar University
- Investigators
- Abdel-Wahab El-Okby, MD, Principal investigator, Al-Azhar UniversityNaglaa Ali Gadallah, MD, Study chair, Ain Shams UniversitySayed Bakry, PhD, Study director, Al-Azhar UniversityRefaat El-Badawy, MD, Study chair, Al-Azhar UniversityHala Gabr, MD, Study chair, Cairo UniversityWael Wael Abu El Khier, MD, Study chair, Military AcademyAnthony Atala, MD, Study chair, Director of the Wake Forest Institute for Regenerative MedicineMostafa Elbahrawy, MSc, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161003
- Sponsor's protocol ID
- Azhar52980070
- Other IDs
- Azhar52980070
- Status last verified
- Jun 2014
- First submitted
- 9 May 2014
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Stem Cells in Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty
- ClinicalTrials.gov ID
- NCT02161003
- Acronym / sponsor ID
- Azhar52980070
- Conditions
- Fecal Incontinence
- Keywords
- Fecal Incontinence, Posterior Sagittal Ano-rectoplasty, Mesenchymal Stem Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Ain Shams University, Affiliated Hospital to Academy of Military Medical Sciences, Wake Forest University Health Sciences
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The problem of the incontinence imposes considerable strain on the child and their parents. These patients suffer from a long-life handicap and they need support and follow-up. The cost associated with these diseases has clearly been illustrated to be a major component in the healthcare spending picture, may be adding hundreds of thousands of dollars to healthcare cost, as well as loss of productivity in the work force. Fecal incontinence treatment has been a difficult challenge for surgeons for several generations until now the current traditional surgical result is unsatisfactory. Mesenchymal Stem Cells injection may represent a new attractive treatment option for anal sphincter lesions. Moreover, experimental injury of muscle of anal sphincter in rats has been successfully treated with stem cells injections. In this study, the investigators will shed more light on the ability of Mesenchymal Stem Cells to induce myogenesis and regenerate anal Sphincter of patients with fecal incontinence. It will be very useful to many Egyptian patients.
Detailed description
A stem cell is capable of forming various tissue under definite signals received from the body. Stem cell research in animals has been an ongoing program in the west with fruitful results. Current challenges with the use of stem cells in clinical practice will be solve the many unanswered queries. To study the potential therapeutic effects of local Mesenchymal Stem cell injection in children presenting with fecal incontinence (FI) after posterior sagittal ano-rectoplasty (PSARP) operation for high imperforate anus. Children whom suffering from FI after PSARP for high imperforate anus will included in this study. Autologous MSC from the upper posterior iliac crest bone marrow sample will be extracted from patients under general anesthesia, in a suitable clean operation room. Will be Cultured and injected into the external anal sphincter defect using direct pena stimulator or ultra sound guidance. Then followed up for 180 days post injection, to assess the ability of mesenchymal stem cells to induce myogenesis of the anal Sphincter of patients with FI after PSARP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cells Isolation | Experimental | Procedure: Stem Cells Injection Technique, Procedure: Stem Cell IsolationStem cell isolation technique and Stem Cells Injection Technique The method of isolation of MSC from bone marrow will be carried out using the Ficoll-Paque technique for the isolation of mononucleated cells followed by the separation of MSC by adherence to plastic. Finally, the cells will be resuspended and counted using a hemocytometer. Mononucleated cells will be cultured and incubated at 37°C in an atmosphere of 95% relative humidity and 5% CO2. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male Childern Ages: above 2 Years old.
- Patient with FI. After PSARP repair of high imperforate anus.
- Absence of parasitic and infective bacterial growth after Stool analysis and stool culture.
- -
Key exclusion criteria (7 listed)
- Any degree of Spinal cord injury, systemic, neuronal paralysis or sacral agenesis.
- Absence of muscle activity detected by EMG.
- Ano-rectal disorders such as tumors, fissures, anal or rectal prolapse, and rectocele.
- Positive stool culture resistant to preoperative oral antibiotic therapy.
- Previous injection of bulking agents at the level of sphincter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem Cells Injection TechniqueInjection of MSCs for the treatment of anal sphincter insufficiency is a potential alternative therapy for imperforate anus patients who have undergone primary PSARP with post-operative FI. In this study a single dose of 1.2 ml MSC will be divided into 12 part of 0.1ml of MSC, doses will be injected into the anal sphincter all around in 12 injection sites according to the clock meridian under general anesthesia without giving muscle relaxant. | Procedure or surgery | Stem Cells Isolation |
| Stem Cell IsolationFrom the upper posterior iliac crest 10 ml bone marrow sample will be extracted from patients using a heparinized syringe, under general anesthesia, in a suitable clean operation room. | Procedure or surgery | Stem Cells Isolation |
Primary outcome
Main outcome measures
Time frame: 24 Weeks
Incontinence Score
4 secondary outcomes
Assessment of Clinical Parameters
Time frame: 24 Weeks
Clinical Assessment
Time frame: 12 Weeks
Clinical Assessment
Time frame: 24 Weeks
Assessment of Urinary sphin Assessment of Urinary Sphincter (Electrophysiology Study)
Time frame: 48 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Refaat Ibrahiem El-Badawy contact
Abdel-Wahab El-Okby, MD principal investigator
Al-Azhar University
Naglaa Ali Gadallah, MD study chair
Ain Shams University
Sayed Bakry, PhD study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stem Cells Injection Technique and Stem Cell Isolation in people with Fecal Incontinence, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Refaat Ibrahiem El-Badawy (+201001567863), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main outcome measures (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.