In Vivo and in Vitro Evaluation of PRP Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hospital Universitario Dr. Jose E. Gonzalez
Sponsor:
Information provided by (Responsible Party):
Mario Alberto Simental Mendia, M Sc, Principal Investigator, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01782885
First received: January 30, 2013
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to test whether the platelet-rich plasma (PRP)intra-articular injection therapy is effective as an alternative treatment option in patients with mild knee osteoarthritis within a controlled randomized study. The investigators will evaluate patients outcome in level of pain and quality of life at 3, 6 and 12 months follow up. The investigators will also analyze the biochemical environment in patient's joint before and after the treatment.

The study will be complemented with in vitro experiments of human osteoarthritic cartilage explants culture (and treated with PRP) for histological and gene expression assays.

PRP intra-articular injections therapy is effective in patients with mild knee osteoarthritis by modifying the biochemical joint environment and cartilage regeneration capability.


Condition Intervention
Osteoarthritis Grade I and II (Kellgren-Lawrence Scale)
Procedure: Intra-articular injection of PRP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In Vivo and in Vitro Evaluation of the Platelet-rich Plasma Treatment in Osteoarthritis.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 0, 1 1/2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    The WOMAC evaluation will be performed on patients who received the treatment at 0, 1 1/2, 3, 6 and 12 months after treatment finished.


Secondary Outcome Measures:
  • Change in Visual Analog Scale (VAS) [ Time Frame: 0, 1 1/2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    The VAS evaluation will be performed on patients who received the treatment at 0, 1 1/2, 3, 6 and 12 months after treatment finished.


Other Outcome Measures:
  • Change in SF-12v2 Health Survey [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]
    The SF-12v2 Health Survey will be performed on patients who received the treatment at 0, 3, 6 and 12 months after treatment finished.


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Acetaminophen
Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts.
Experimental: Intra-articular injection of PRP
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks
Procedure: Intra-articular injection of PRP
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years old
  • Patients who haven't received steroids injection or medical treatment 1 month before the study
  • Patients with knee osteoarthritis grade I and II (Kellgren-Lawrence scale)
  • Indistinct gender
  • Patients who accept to participate in the study with previous signed informed consent

Exclusion Criteria:

  • Patients with knee osteoarthritis grade III and IV (Kellgren-Lawrence scale)
  • Patients with prosthesis
  • Pregnancy
  • Patients with rheumatic diseases
  • Patients with diabetes, hepatic diseases, coagulopathy, cardiovascular diseases, immunosuppression, infections
  • Patients taking anticoagulants
  • Patients with concentrations of hemoglobin under 11 g/dL and platelets under 150,000/uL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782885

Contacts
Contact: Felix Vilchez, PhD +52 (81) 8346 2310 vilchez.doctor@gmail.com

Locations
Mexico
Hospital Universitario Dr. José E. González Recruiting
Monterrey, Nuevo León, Mexico, 64460
Contact: Mario A. Simental, MSc       mario.simental@gmail.com   
Contact: Felix Vilchez, PhD       vilchez.doctor@gmail.com   
Principal Investigator: Mario A. Simental, MSc         
Principal Investigator: Felix Vilchez, PhD         
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: Mario A. Simental, MSc Universidad Autónoma de Nuevo León, Facultad de Medicina
Study Director: Felix Vilchez, PhD Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José E. González
Study Director: Herminia G Martínez, PhD Universidad Autónoma de Nuevo León, Facultad de Medicina
  More Information

Publications:
Responsible Party: Mario Alberto Simental Mendia, M Sc, Principal Investigator, M. Sc., Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01782885     History of Changes
Other Study ID Numbers: BI13-001
Study First Received: January 30, 2013
Last Updated: January 31, 2014
Health Authority: Mexico: Research Ethics Committee from Facultad de Medicina and Hospital Universitario Dr. Jose Eleuterio Gonzalez

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Osteoarthritis
Platelet-Rich Plasma
Intra-articular
Injection

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014