BPC-157 registration describes planned randomized trial in 20 rotator cuff repair patients

This is a trial registration, not a results report. It describes a planned study in humans: the text states that twenty patients undergoing arthroscopic rotator cuff repair will be enrolled and randomly assigned to receive either BPC-157 or a saline placebo.

The registration characterizes the design as a randomized, double-blind, placebo-controlled pilot trial investigating effects on tendon healing and functional recovery after arthroscopic rotator cuff repair. The stated goal is to evaluate safety, feasibility, and preliminary efficacy, with results intended to inform the design of a future larger-scale clinical trial.

According to the registration, tendon healing will be assessed using postoperative MRI, patient-reported outcome measures, range of motion, and muscle strength measured via handheld dynamometry. Blood samples are also planned to evaluate biomarkers associated with collagen turnover and inflammation.

The arm descriptions list an experimental BPC-157 group and a sham comparator. The sham text describes participants receiving normal saline by daily subcutaneous injection, while the intervention description separately describes a sham group receiving no active treatment or placebo injections as a no-treatment control. The registration text contains both descriptions.

The registration states that participants will self-administer subcutaneous injections daily for 90 days following surgery, and that BPC-157 will be self-administered via subcutaneous injection once daily for 90 days following arthroscopic rotator cuff repair. The saline comparator is described with the same schedule. The registration text does not state a milligram amount per injection, so no quantity can be reported here.

This is a registration describing planned work, so it reports no outcomes, no safety findings, and no efficacy data. The planned sample described in the narrative text is twenty patients, which the registration itself calls a pilot study intended to inform a larger future trial; a sample that size limits the precision of any later estimate.

The record is internally inconsistent about the comparator, describing both a saline placebo and a no-treatment sham group. No dose amount per injection is stated, and the registration does not name a funding source or site in the provided text. The registration also states that BPC-157 has not undergone formal human clinical trials.

The registration itself states that BPC-157 remains an investigational compound not approved by the FDA. Per the site's regulatory review, BPC-157 is not an FDA-approved drug for any use.