Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome

Overseen By Jose W Ricardo, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must not be taking: Any medication

Disqualifiers: Psoriasis, Lichen planus, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

11 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you must stop taking any medications at least 90 days before the study starts.

What data supports the effectiveness of the treatment Platelet-poor plasma, Platelet-rich plasma?

Research on platelet growth factors, like thrombopoietin, shows they can effectively increase platelet production, which is important for treating conditions with low platelet counts. For example, oprelvekin, a platelet growth factor, has been shown to reduce the need for platelet transfusions in cancer patients undergoing chemotherapy. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research articles provided do not contain specific safety data for the treatment under the names Platelet-poor plasma or Platelet-rich plasma. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How is platelet-rich plasma treatment different from other treatments?

Platelet-rich plasma (PRP) is unique because it uses a concentrated form of your own blood's platelets, which are rich in growth factors that can help repair and regenerate tissues. Unlike other treatments, PRP is derived from your own blood, making it an autologous (self-derived) therapy, and it has been shown to enhance cell growth and tissue healing in various medical fields. ^{11 12 13 14 15}

What is the purpose of this trial?

This trial is testing a treatment where a patient's own blood is used to help heal and strengthen weak, breakable nails. The treatment aims to use special components in the blood to repair the nails.

Research Team

Shari R Lipner, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with brittle nails.

Must understand and voluntarily sign an informed consent form

Must be able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

You have a severe skin condition, such as psoriasis or fungal infection, that affects your fingernails.

Use of any medication within 90 days prior to start of study

Inability of the patient to provide written informed consent for any reason.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of platelet-rich plasma or platelet-poor plasma into the proximal nail folds

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Platelet-poor plasma
• Platelet-rich plasma

Participant Groups

Group I: Platelet-rich plasma Experimental Treatment 1 Intervention

The proximal nail fold is cleansed with alcohol and platelet-rich plasma obtained from the patient is injected using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-rich plasma is injected into 8 proximal nail folds.

Group II: Platelet-poor plasma Placebo Group 1 Intervention

The proximal nail fold is cleansed with alcohol and platelet-poor plasma obtained from the patient is injected using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-poor plasma is injected into 2 proximal nail folds.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Eclipse Aesthetics, LLC

Collaborator

Trials

3

Recruited

80+

Findings from Research

Interleukin-11 has been approved by the FDA for reducing severe thrombocytopenia in patients undergoing intensive chemotherapy, demonstrating its efficacy in this specific context.

While thrombopoietin and its analogues are potent stimulators of platelet production with few side effects, their effectiveness in preventing severe thrombocytopenia during leukemia treatment and bone marrow transplants has been disappointing, and some can induce harmful antibodies that lead to thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical biology and potential use of thrombopoietin. Basser, R.[2019]

Avatrombopag significantly increased platelet response in patients with thrombocytopenia compared to placebo, with a notable absolute increment in platelet count of 31.13%.

While avatrombopag was effective, it was associated with a slightly higher incidence of adverse events compared to placebo, although serious adverse events and mortality rates were not significantly different.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Avatrombopag in Patients With Thrombocytopenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Li, C., Li, X., Huang, F., et al.[2020]

Platelet-rich plasma (PRP) significantly enhances the proliferation of human adipose-derived stem cells (hASCs), primarily through the action of platelet-derived growth factor (PDGF)-BB.

The proliferation induced by PRP is mediated via specific signaling pathways, including ERK1/2, PI3K/Akt, and JNK, while inhibitors like imatinib and sorafenib can effectively block this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma enhances the proliferation of human adipose stem cells through multiple signaling pathways. Lai, F., Kakudo, N., Morimoto, N., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Thrombopoietin therapy increases platelet yields in healthy platelet donors. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Incorporating new modalities into practice guidelines: platelet growth factors. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Thrombopoietin and the TPO receptorduring platelet storage. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Clinical biology and potential use of thrombopoietin. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The use of PEG-rhuMGDF in platelet apheresis. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Improving multiple sclerosis management and collecting safety information in the real world: the MSDS3D software approach. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Avatrombopag in Patients With Thrombocytopenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Incidence of Treatment-Related Adverse Events of Thrombopoietin Receptor Agonists in Adults with Immune Thrombocytopenia: A Systematic Review and Network Meta-Analysis of Randomized Controlled Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

High incidence of clopidogrel-associated gastrointestinal bleeding in patients with previous peptic ulcer disease. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Toxicities of the thrombopoietic growth factors. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma enhances the proliferation of human adipose stem cells through multiple signaling pathways. [2022]

12. Mexico pubmed.ncbi.nlm.nih.gov

[Platelets-rich plasma: a versatile tool for regenerative medicine?]. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Adult and umbilical cord blood-derived platelet-rich plasma for mesenchymal stem cell proliferation, chemotaxis, and cryo-preservation. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Classification and coding of platelet-rich plasma derived from New Zealand white rabbits for tissue engineering and regenerative medicine applications. [2022]

15. Japan pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma releasate promotes angiogenesis in vitro and in vivo. [2022]