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

Assessment of autologous implantation of human Adipose derived stem cells in augment of lower esophageal sphincter weakness leading to gastroesophageal reflux

Two arm parallel group controlled randomized double blind clinical trial phase l

This study will be done at the Rasoul-e-Akram Hospital of Iran University of Medical Sciences, Tehran, Iran. Preparation of suspensions (with cell and without cell), cell injection, examinations, and data collection by blind researchers are conducted. The patient with personal consent will be blind to the study and with block randomization (block size 3) are divided into 2 groups (N = 12): Control group: Gastroesophageal reflux by injection of PBS. Cell group: Gastroesophageal reflux with 8 million cells injection. Patients in the first, second week and first month (side effects), as well as the third and sixth months after injection (endoscopy and sphincter pressure measurements) are examined.

Inclusion criteria: Age of 18 to 60, without hiatal herniation, without barretts, without chronic disease, without pregnancy, without morbidly obese, gastroesophageal reflux, weakness of the lower esophageal sphincter Exclusion criteria: Very old, chronic illnesses, congenital esophageal disorders, participation in a clinical trial within the last 6 months, severe weight gain, without personal consent

Intervention group 1: Patients with gastroesophageal reflux due to the weakness of the lower esophageal sphincter that will be injected 8 million cells suspended in 3 ml buffered phosphate solution in the lower esophageal sphincter. Intervention group 2: Patients with gastroduodenal reflux due to the weakness of the esophagus sphincter that will be injected 3 ml phosphate buffer solution in the lower esophageal sphincter.

The power of sphincter

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.

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.