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Platelet rich plasma

Phase 3

Coxarthrosis | Small molecule | Musculoskeletal |Design Therapeutics, Inc.|Last Updated: Feb 22, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

Platelet rich plasma · 1 trial · 1 indication

Phase 3 1
NCT02694146Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in CoxarthrosisCoxarthrosis
COMPLETED74 Analytics
PHASE3COMPLETED
Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
CoxarthrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

EVA scale for pain measure.
Through study completion, an average of 1 year.

The patient assesses the sensation of pain following a horizontal visual analog scale (EVA) with values between 0 ("no pain") and the value 100 ("excruciating pain"). The records taken are recorded in the medical record of the patient.

Harris Hip Score for pain, function and range of motion measure.
Through study completion, an average of 1 year.

It is a questionnaire developed to evaluate hip surgery or replacement. It is widely used for evaluation of hip disorders and treatment methods.

WOMAC questionnaire for pain, stiffness and joint mobility measure.
Through study completion, an average of 1 year.

It is a standardized questionnaire, widely used for assessment of both knee and hip osteoarthritis. It consists of five items for assessing pain (range 0-20), two items that assess the stiffness (range 0-8) and 17 items that evaluate the functionality of the joint (range 0-68).

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PRP (platelet rich plasma)EXPERIMENTAL37 patients with coxarthrosis are treated with 6ml of PRP (platelet rich plasma), obtained from blood extracted from patients in the 20 minutes prior to infiltration thereof. For PRP administration: * The injection should be performed at room temperature. * The administration should be carried out under aseptic conditions. * The patient will be placed in the supine position and the administration will be performed by an anterolateral approach. * The PRP is injected into the synovial space.
Hylan G-F 20 (Synvisc-One ®)ACTIVE_COMPARATOR37 patients with coxarthrosis are treated with a pre-filled syringe of hyaluronic acid 60mg / 6ml (Synvisc-One ®). It is necessary to remove synovial fluid before injecting Hylan G-F 20. * The injection should be performed at room temperature. * The administration should be carried out under aseptic conditions. * The patient will be placed in the supine position and the administration will be performed by an anterolateral approach. * The Hylan G-F 20 is injected into the synovial space. * After injecting Hylan G-F 20 the patient should stand 5 minutes.

Interventions

NameTypeDescription
Platelet rich plasmaDRUGPlatelet rich plasma (PRP) is a platelet concentrated obtained from autologous blood centrifugation. This concentration technique provides larger amounts of biologically active molecules, mainly growth factors that are responsible for tissue repair. PRP (platelet rich plasma) contains a higher concentration of platelets from baseline (150,000-350,000 / ul).
Hylan G-F 20DRUGHylan G-F 20 is a viscous, sterile and non-pyrogenic elasto fluid containing hylan. Hylans are byproducts from hyaluronate (hyaluronic acid sodium salt), consisting of repeating disaccharides of N-acetylglucosamine and sodium glucuronate. Hylan G-F 20 replaces and supplements the synovial fluid. It is effective at any stage of the joint pathology.
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Eligibility Criteria

Age Range30 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients\> 30 years. * Patients who voluntarily express their intention to participate by informed consent. * Diagnosis of coxarthrosis who have failed conservative treatments for 6 months * Women of childbearing potential must have a negative pregnancy test during screening a...

Countries:Spain
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Frequently asked questions about Platelet rich plasma

What is Platelet rich plasma used for in Coxarthrosis?

Platelet rich plasma is being studied for the treatment of Coxarthrosis, a form of osteoarthritis of the hip. It is an investigational small molecule therapy in Phase 3 clinical development. The treatment is being evaluated for its potential to address this musculoskeletal condition, though it is not yet approved.

What does Platelet rich plasma target?

Platelet rich plasma does not have a specific molecular target or target class identified. Its mechanism of action is not defined by a single molecular target, as it is a biologic preparation derived from blood. The therapy is being investigated for its effects in Coxarthrosis, but the precise biological pathway is not specified.

Who makes Platelet rich plasma?

Platelet rich plasma is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker DSGN. The company is conducting clinical research on this therapy for Coxarthrosis, a musculoskeletal condition affecting the hip joint.

What phase is Platelet rich plasma in?

Platelet rich plasma is in Phase 3 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the therapy is being evaluated for its safety and efficacy in patients with Coxarthrosis.

What clinical trials is Platelet rich plasma in?

Platelet rich plasma has one completed Phase 3 clinical trial, identified as NCT02694146. This randomized, double-blind, active-controlled study enrolled 74 participants with Coxarthrosis in Spain. The trial evaluated the use of platelet rich plasma compared to hyaluronic acid, and it included biomarker selection.

Is Platelet rich plasma the same as PRP?

Platelet rich plasma is commonly abbreviated as PRP, though this alternative name is not explicitly provided in the available data. The therapy is being developed by Design Therapeutics for Coxarthrosis and is currently in Phase 3 clinical trials. No other alternative names have been identified for this investigational treatment.