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IRCT20181113041635N2 IRCT 2019-08-16 Iran University of Medical Sciences Strengthening the weakness of the lower esophageal sphincter leads to reflux with stem cells derived from human adipose tissue. Results assessment of autologous implantation of human Adipose derived stem cells in augment of lower esophageal sphincter weakness leading to gastroesophageal reflux : a phase I clinical trial 2019-07-23 anticipated 24 Complete https://irct.ir/trial/39245 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be based on the block randomization method. Randomization will be done by a web software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The number of patients required per group (based on sample size determination) was estimated 12 patients per group (24 patients totally). Therefore, considering three random block sizes (4, 6 and 8), we will define blocks for randomization of patients. It is worth noting that random block design in the mentioned web software will be done by another researcher who is not involved in the process of sampling and following up patients. The patient assignment sequence to the study groups is only available to the researcher, and at the time of each patient's visit to the treatment center, the sampling physician will make a phone call to the randomized design researcher to get the patient in the right group. It is worth noting that the groups will be named Group A and Group B, and the physicians involved in the treatment and follow-up of patients will not be aware of the group's original name, Blinding description: Patients are given code. The patient is blind to the study (he/she does not know whether receives cell or placebo). An endoscopic expert who injects cell suspension or the liquid in which the cell is suspended by endoscopy is blind to the study. The researcher (collector of data during post-intervention follow-up) is blind to the study. 1 Gastroesophageal reflux. Intervention 1: Intervention group: Injection of 8 million stem cells derived from human adipose tissue injection, suspended in 3 ml buffer phosphate solution, by endoscopy in the lower esophageal sphincter of patients with gastroesophageal reflux. Intervention 2: Control group: Injection of 3 ml of liquid in which the cell is suspended, by endoscopy in the lower esophageal sphincter of patients with gastroesophageal reflux. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Arash Sarveazad
Rasoul Akram Hospital, Niayesh street, Sattarkhan Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4790 Arashsarveazad@gmail.com Iran University of Medical Sciences scientific Arash Sarveazad
Rasoul Akram Hospital, Niayesh street, Sattarkhan Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 66554790 Arashsarveazad@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 60 years Without hiatal herniation Without barretts esophagus Without chronic disease Without pregnancy Without morbidly obese Gastroesophageal reflux Proven weakness of the lower esophageal sphincter 18 years 60 years Both Those who are very old and it is difficult to get data from them Individuals with chronic illnesses, such as heart or kidney failure, and it is difficult to get data from them Individuals with congenital esophageal disorders Individuals who participated in a clinical trial within the last 6 months Those who have severe weight gain and it is difficult to get data from them Individuals who do not have personal consent to participate in the study K21.9 Oesophageal reflux NOS Treatment - Other Other Intervention group: Injection of 8 million stem cells derived from human adipose tissue injection, suspended in 3 ml buffer phosphate solution, by endoscopy in the lower esophageal sphincter of patients with gastroesophageal reflux Control group: Injection of 3 ml of liquid in which the cell is suspended, by endoscopy in the lower esophageal sphincter of patients with gastroesophageal reflux Esophageal sphincter pressure. Timepoint: At the beginning of the study (before the intervention), the first week after the intervention, the second week after the intervention, the first month after the intervention, the third month after the intervention and the sixth month after the intervention. Method of measurement: manometry. Iran University of Medical Sciences Approved 2018-05-26 Ethics committee of Iran University of Medical Sciences Deputy of Research and Technology, Iran University of Medical Sciences, next to Milad Tower, Shahid Hemmat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)