Low Molecular Weight Peptides from Hydrolyzed Collagen — Clinical Brochure, 2024 Update

Document

Clinical brochure, 2024 update – low molecular weight peptides (LWPs) from hydrolyzed collagen.

Manufacturer

Tiss’You

Report

Clinical summary report, updated January 2024.

Document code

CB012424EN00

Updated January 2024.

Published study

1

Completed PMCF studies

6

Ongoing PMCF study

1

Ongoing EC-approved randomized controlled trials

3

Patients enrolled in studies

300+

Investigated clinical applications

7

Publication

Effectiveness of hydrolyzed collagen peptide injection for the treatment of collateral ligament pain: a randomized controlled trial.

Authors

Binh Luu Thi, Lan Tran Thi, Minh Hang Hoang. Journal of clinical & medical surgery vol. 3; 2023.

Site

Thai Nguyen University of Medicine and Pharmacy, Vietnam

Patients

62 patients

Indication

Collateral ligament pain

Follow-up

6 months

Treatment

5 mg/ml (1 ml) LWPs vs. corticosteroid

• Better pain relief and functional improvement at 3 and 6 months after LWPs injection in comparison with corticosteroid injection.
• No observation of any significant differences in ultrasound lesions between the two groups, despite the clinical improvement observed in the collagen peptides group.
• Higher satisfaction rate in patients who received LWPs injection instead of corticosteroid injection.
• No adverse events were reported during the study.

Purpose

Collateral ligament pain is a musculoskeletal condition causing knee inflammation, often affecting athletes. Despite various treatments being available, there is failure in addressing the pathophysiologic collagen degradation. Hydrolyzed collagen peptides may help damage tissues in the repairment process, but until now no data is available on local injection of collagen peptides, with data available only on oral supplementation.

Methods

A randomized controlled trial assessed the efficacy of hydrolyzed collagen peptide injections (Tiss’You, Republic of San Marino) for persistent collateral ligament pain. Sixty-two patients with ultrasound-confirmed inflammation were divided into two groups. The study group (31 patients) received oral painkillers and a collagen peptide injection, while the control group (31 patients) received oral painkillers and a depo-medrol injection.

Results

The study group showed significant improvement in pain relief, functional status, and quality of life, measured by the Visual Analogue Scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) after six months. Ultrasound confirmed ligament healing in both groups with no observed differences. The study group reported higher satisfaction and no adverse effects.

Conclusion

Hydrolyzed collagen peptide injections may effectively and safely treat collateral ligament pain. This study offers insights into this novel emerging treatment option, exploiting the ability of collagen peptides in helping tissue repair. Further research with larger samples and longer follow-up is necessary to validate these findings.

PMCF study

Intra-articular injection of hydrolyzed collagen peptides for the treatment of knee osteoarthritis.

Investigator

Federico Valli

Site

Milan, Italy

Patients

20 patients

Indication

Knee osteoarthritis, II-III Kellgren-Lawrence grade

Follow-up

12 months

Treatment

5 mg/ml (2 ml) LWPs

• Solid knee pain relief and functional improvement after one injection.
• Stable performance during the follow-up with the best results at 12 months.
• No adverse events reported.

PMCF study

Double intra-articular injection of hydrolyzed collagen peptides for the treatment of knee and hip osteoarthritis.

Investigator

Francesco Fiacchi

Site

Mantua, Italy

Patients

20 patients

Indication

Knee and hip osteoarthritis, I-II-III Kellgren-Lawrence grade

Follow-up

6+1 months

Treatment

5 mg/ml (2 ml) LWPs, injection at 0 and 6 months

• Significant pain relief after first injection, with further increase 1 month after the second injection.
• The knee subgroup showed better performance than the hip subgroup.
• No adverse events reported.

PMCF study

Intra-articular injection of hydrolyzed collagen peptides for the treatment of rizoarthrosis.

Investigators

Donato Cortese, Paola Bortot

Site

Treviso, Italy

Patients

15 patients

Indication

Rizoarthrosis, I-II grade

Follow-up

6 months

Treatment

5 mg/ml (2 ml) LWPs

• Significant pain reduction (2-point drop in VAS score) at 1 and 3 months.
• Sustained functional improvement (QuickDASH and Abilhand), with partial loss at 6 months.
• No adverse events reported.

PMCF study

Hydrolyzed collagen peptide injection for the treatment of epicondylitis.

Investigator

Francesco Porta

Site

Pistoia, Italy

Patients

13 patients

Indication

Epicondylitis, I-II grade

Follow-up

45 days

Treatment

5 mg/ml (1 ml) LWPs

• Pain reduction observed in most patients, some had limited improvements and required further treatment.
• Ultrasound evidence of positive changes in tendon health and Power-doppler evidence of reduced inflammation.
• No adverse events reported.

PMCF study

Hydrolyzed collagen peptide injection for the treatment of cuff rotator partial tears.

Investigators

Luca Latini, Francesco Porta, Vincenzo Maccarrone, Davide Zompa, Edoardo Cipolletta, Riccardo Mashadi Mirza, Emilio Filippucci

Site

Senigallia, Italy

Patients

21 patients

Indication

Partial or small full-thickness supraspinatus tendon tears (<1 cm)

Follow-up

12 weeks

Treatment

5 mg/ml (1 ml) LWPs

• VAS (pain) improved in 81% and SPADI score (functionality) improved in 85.7% at 12 weeks after one injection.
• Great ultrasound-guided injection tolerance, only one case with tendon tear progression at 12 weeks.
• No adverse events reported.

PMCF study

Intra-dermal injection along the thoracolumbar region of hydrolyzed collagen peptides for the treatment of back pain.

Investigators

Maciej Materkowski, Paweł Rogóź, Cezary Rychniewicz, Andrzej Przybycień, Wiesław Kamiński

Site

Poland

Patients

28 patients

Indication

Low back pain

Follow-up

2 months

Treatment

1 mg/ml (10 ml) LWPs

• Halved pain and improved functionality in patients with low back pain treated at 2 months after one injection.
• Minor swelling and pain observed at 2 months only in 2 out of 28 patients.
• No adverse events reported.

Study

Randomized comparative study on the anti-inflammatory and regenerative efficacy of hydrolyzed collagen peptides in patients with femoroacetabular impingement undergoing hip arthroscopy.

Investigator

Enrico Tassinari

Site

Rizzoli Orthopaedic Institute – Bologna, Italy

Patients

40 patients, 20 vs 20, RCT

Indication

Hip osteoarthritis

Comparison

LWPs vs. Cortison, both associated with arthroscopic treatment.

Timeline

Study completion / data analyzed – manuscript draft (now) – publication (2024 Q2 estimated).

Study

Hydrolyzed collagen vs. placebo in the treatment of degenerative knee cartilage lesions.

Investigators

Alessandro Di Martino, Luca Andriolo, Giuseppe Filardo, Stefano Zaffagnini

Site

Rizzoli Orthopaedic Institute – Bologna, Italy

Patients

204 patients, 102 vs 102, RCT with cross-over

Indication

Knee osteoarthritis

Comparison

LWPs vs. Placebo (saline)

Timeline

EC approval – recruitment (now) – study completion (2025 Q2 estimated).

Study

Plantar fasciitis treatment: a prospective randomized comparison between shockwaves and collagen peptides.

Investigators

Silvana De Giorgio, Lorenzo Moretti, Biagio Moretti

Site

Policlinico di Bari, Italy

Patients

60 patients, 20 vs 20 vs 20, RCT

Indication

Plantar fasciitis

Comparison

LWPs vs. LWPs with Ultrasound vs. Ultrasound only

Timeline

EC approval – recruitment (now) – study completion (2025 Q2 estimated).