Is BPC-157 safe for use in humans? Is there evidence that BPC-157 use in humans facilitates muscle & tendon healing? Is there current research in this area in humans?

Comment by InpharmD Researcher

While clinical trials conducted in Croatia in the early 2000s determined BPC 157 to be safe and effective in humans for the treatment of inflammatory bowel disease, there appears to be a lack of trials conducted in the U.S. to suggest BPC 157 is safe for use in humans. Despite the lack of human study, BPC 157 is a peptide derived from human gastric juices; thus, expert opinion suggests some level of safety in human subjects may be assumed. Available data indicating BPC 157 can facilitate muscle and tendon healing are limited to rat and in vitro studies, with one small, low-quality observational study in humans determining BPC 157 can help improve knee pain (see Table 1). A phase 1 clinical trial was conducted to evaluate the safety and pharmacokinetics of BPC 157 compared to placebo in healthy volunteers, with results reportedly submitted to ClinicalTrials.gov on May 23, 2016. However, the trial is listed as canceled, which indicates the study sponsor or investigator recalled a submission of study results before quality control review took place. Additional ongoing research of BPC 157 in humans could not be identified.

Background

A 2019 review discussing the role of gastric pentadecapeptide body protection compound BPC 157 in accelerating musculoskeletal soft tissue healing notes that BPC 157 has shown significant promise in healing of various tissues including tendons, ligaments, skeletal muscles, and bones. However, data supporting the use of BPC 157 for described musculoskeletal benefits are limited to rat and in vitro studies; studies evaluating the use of BPC 157 in humans were not described. It was specified that the most robust studies available evaluate the potential mechanisms surrounding the healing effects of BPC 157, but study in humans was not described. While the use of rodents and small mammals is common for the development of novel therapeutic agents, it is recommended that caution should still be utilized when extrapolating available research to the clinical setting. [1]

Additionally, the authors indicate that there is still a requirement for successful human trials to be completed prior to clinical translation as there are important differences between rodent and human physiology that could have a significant impact on the efficacy and safety of any agent. Despite the lack of human study, it should be taken into account that BPC 157 is a peptide derived from human gastric juices; thus, some level of safety in human subjects may be assumed. Regardless, the clinical safety in humans is still largely unknown. A review discussing BPC 157 as a potential treatment for COVID-19 echoes similar issues with available data surrounding BPC 157, but does note that BPC 157 has been proven to be efficacious and safe in clinical trials evaluating its use for inflammatory bowel disease (mild to moderate ulcerative colitis). However, these clinical trials were conducted in Croatia and published in the early 2000s; U.S. trials evaluating the efficacy or safety of BPC 157 in humans were not described. [1], [2], [3], [4]

A 2021 retrospective study conducted at the Institute for Hormonal Balance in Orlando, Florida, that evaluated the use of BPC 157, alone or in combination with thymosin-beta-4 (TB4), indicates in its methodology that no human clinical trials evaluating the use of BPC 157 to help with knee pain have been published (see Table 1). [5]

According to ClinicalTrials.gov, a phase 1 pilot study was conducted to assess the safety and pharmacokinetics of PCO-02 (Bepecin; active ingredient BPC 157) compared to placebo in healthy volunteers. Results were reportedly submitted to ClinicalTrials.gov on May 23, 2016, but the study itself is listed as canceled, which indicates the study sponsor or investigator recalled a submission of study results before quality control review took place. [6]

References:

[1] Gwyer D, Wragg NM, Wilson SL. Gastric pentadecapeptide body protection compound BPC 157 and its role in accelerating musculoskeletal soft tissue healing. Cell Tissue Res. 2019;377(2):153-159. doi:10.1007/s00441-019-03016-8
[2] Deek SA. BPC 157 as Potential Treatment for COVID-19 [published online ahead of print, 2021 Nov 9]. Med Hypotheses. 2021;158:110736. doi:10.1016/j.mehy.2021.110736
[3] Veljaca M., Sladoljev D., Mildner B. Safety, tolerability and pharmacokinetics of PL 14736, a novel agent for treatment of ulcerative colitis, in healthy male volunteers. Gut. 2003;51:A309.
[4] Ruenzi M. A multicenter, randomized, double blind, placebo-controlled phase II study of PL 14736 enema in the treatment of mild-to-moderate ulcerative colitis. Gastroenterology. 2005;128:A584.
[5] Lee E, Padgett B. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Altern Ther Health Med. 2021;27(4):8-13.
[6] ClinicalTrials.gov. PCO-02 - Safety and Pharmacokinetics Trial. Updated December 22, 2015. Accessed October 29, 2023. https://classic.clinicaltrials.gov/ct2/show/study/NCT02637284
Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

Is BPC-157 safe for use in humans? Is there evidence that BPC-157 use in humans facilitates muscle & tendon healing? Is there current research in this area in humans?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→


Please see Table 1 for your response.

 

Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain

Design

Single-center, retrospective observational study

N= 16

Objective

To determine whether intra-articular injection of BPC157, alone or combined with thymosin-beta-4 (TB4), helps relieve knee pain

Study Groups

BPC157 alone (n= 12)

BPC157 + TB4 (n= 4)

Inclusion Criteria

Patients with multiple types of knee pain

Exclusion Criteria

Showed signs of infection or received total knee replacement; pregnant women; age ≤ 10 years; undergoing cancer treatment

Methods

Patients received 2 mL injection of BPC157 (2,000 mcg/mL) into the knee via the medial tibia plateau area or an intra-articular injection of BPC157 with TB4 ranging from 1 mL BPC157 plus 1 mL TB4 (3,000 mcg/mL) to 2 mL BPC157 plus 2 mL of TB4. It was noted that a combination of BPC157 and TB4 was used in the beginning, but after 4 patients, the researcher wanted to test whether BPC157 alone would be effective.

Pain was evaluated before and after the injection on the basis of a 0 to 10 scale, with 10 being the worst. Additionally, pain was measured based on the degree of mobility, tolerance for exercise, ability to climb stairs, and quality of sleep.

Duration

2019 to 2020

Outcome Measures

Improvement in knee pain, duration of knee pain improvement

Baseline Characteristics

  

Patients (N= 16)

Age, years (range)

 60 (19 to 77) 

Female

9 (56%) 

White

 14 (87.5%) 

Previous diagnosis of osteoarthritis of the knee

 5 (31%)

Results

Endpoint

BPC157 alone (n= 12)

BPC157 + TB4 (n= 4)

Improvement in knee pain

 11 (92%) 3 (75%)

Duration of knee pain improvement

24 hours

Up to 3 months

3 to 6 months

6 months to 1 year


1 (8.3%)

2 (16.7%)

2 (16.7%)

7 (58.3%)


Data not provided

1 (25%)

1 (25%)

2 (50%)

Adverse Events

None reported

Study Author Conclusions

This small study suggests that intra-articular injection of BPC-157 helps with multiple types of knee pain.

InpharmD Researcher Critique

This study is highly limited by its single-center, single-researcher design, which introduces bias and confounding to the results. It was indicated the researcher himself determined he wanted to stop injecting both agents after the first 4 patients. All measurements in this study were subjective, limiting conclusions regarding the safety and efficacy of BPC157 in humans.



References:

Lee E, Padgett B. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Altern Ther Health Med. 2021;27(4):8-13.