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Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma (CMM-PRGF/ART)

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ClinicalTrials.gov Identifier: NCT02365142
Recruitment Status : Unknown
Verified October 2017 by Clinica Universidad de Navarra, Universidad de Navarra.
Recruitment status was:  Active, not recruiting
First Posted : February 18, 2015
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Study Description
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Brief Summary:

Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF) in patients with knee osteoarthritis.

Patients and methods

Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:

  1. Group A: 3 intra-articular injections of platelet rich plasma (PRGF®) separated by 7 days.
  2. Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days and one with Mesenchimal stems cells. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.

In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:

  • Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
  • Radiographic (baseline and 12 months from treatment): Femorotibial space.
  • Radiographic using MRI (baseline and 12 months from treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: 100 million Bone marrow mesenchimal stem cells Biological: Platelet Rich plasma (PRGF) Phase 1 Phase 2

Detailed Description:

Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF®) in patients with knee osteoarthritis.

Patients and methods

Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:

  1. Group A: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days.
  2. Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days and one with Mesenchimal stem cell. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.

The autologous mesenchymal stem cells are obtained from the iliac crest under local anesthesia and sedation. They are cultured ex vivo The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.

In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:

  • Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
  • Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
  • Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.

All patients met the following inclusion and exclusion criteria:

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase I/II. Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma(PRGF)
Study Start Date : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Platelet Rich Plasma (PRGF)
Platelet Rich plasma (PRGF) 3 intraarticular onjections sepataded by 7 days.
 Biological: Platelet Rich plasma (PRGF)
3 injections of PRGF
Active Comparator: BMMSC with Platelet Rich Plasma (PRGF)
Single intraarticular injection of 100 million Bone marrow mesenchimal stem cells and three intraarticular injections of plateler Rich Plasma (PRGF) separatede by 7 days.
 Biological: 100 million Bone marrow mesenchimal stem cells
100 million Bone marrow mesenchimal stem cells with PRGF

Biological: Platelet Rich plasma (PRGF)
3 injections of PRGF


Outcome Measures
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Primary Outcome Measures :
  1. Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS) [ Time Frame: Day 1 ]
    Baseline Visual analogue scale (VAS) prior to the initial dose on day 1

  2. Baseline value of knee injury and osteoarthritis outcome score (Koos). [ Time Frame: Day 1 ]
    Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).

  3. Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC). [ Time Frame: Day 1 ]
    Universities Osteoarthritis Index score (WOMAC).

  4. Baseline SF-36 value [ Time Frame: Day 1 ]
    Baseline SF-36 value

  5. Baseline euroquol 5D value [ Time Frame: Day 1 ]
    Pretreatment euroquol 5D value

  6. Baseline Lequesne index [ Time Frame: Day 1 ]
    Prior to the intervention on day 1 Lequesne index

  7. Baseline femorotibial distance [ Time Frame: Day 1 ]
    Prior to the intervention femoritibial distance on rosenberg x-ray view

  8. Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Follow up (up to 12 months) ]
    Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events During the follow up

  9. Visual analogue scale (VAS) at 1 month [ Time Frame: 1 month ]
    Visual analogue scale (VAS) at on month

  10. Visual analogue scale (VAS) at 3 months [ Time Frame: 3 months ]
    Visual analogue scale (VAS) at 3 months

  11. Visual analogue scale (VAS) at 6 months [ Time Frame: 6 months ]
    Visual analogue scale (VAS) at 6 months

  12. Visual analogue scale (VAS) at 12 months [ Time Frame: 12 months ]
    Visual analogue scale (VAS) at 12 months

  13. Value of knee injury and osteoarthritis outcome score (Koos) at 1 month [ Time Frame: 1 month ]
    Value of knee injury and osteoarthritis outcome score (Koos) at 1 month

  14. Value of knee injury and osteoarthritis outcome score (Koos) at 3 month [ Time Frame: 3 Months ]
    Value of knee injury and osteoarthritis outcome score (Koos) at 3 month

  15. Value of knee injury and osteoarthritis outcome score (Koos) at 6 month [ Time Frame: 6 months ]
    Value of knee injury and osteoarthritis outcome score (Koos) at 6 month

  16. Value of knee injury and osteoarthritis outcome score (Koos) at 12 months [ Time Frame: 12 months ]
    Value of knee injury and osteoarthritis outcome score (Koos) at 12 months


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between 40 and 80 year old
  • Bad results with previous hyaluronic acid injection
  • Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology)
  • Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS)
  • Radiological Classification: Kellgren-Lawrence scale greater or equal to 2
  • Body mass index between 20 and 35 kg/m2
  • Ability to follow during the study period

Exclusion Criteria:

  • Bilateral Osteoarthritis of the Knee requiring treatment in both knees
  • Previous diagnosis of polyarticular disease
  • Severe mechanical deformation
  • Arthroscopy during the previous 6 months
  • Intraarticular infiltration of hyaluronic acid in the last 6 months
  • Systemic autoimmune rheumatic disease
  • Poorly controlled diabetes mellitus
  • Blood dyscrasias
  • Immunosuppressive or anticoagulant treatments
  • Treatment with corticosteroids in the 3 months prior to inclusion in the study
  • NSAID therapy within 15 days prior to inclusion in the study
  • Patients with a history of allergy to penicillin or streptomycin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365142


Locations
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Spain
Hospital Universitario de Salamanca
Salamanca, Castilla-León, Spain, 37007
Departamento Cirugía Ortopédica y Traumatología. Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Principal Investigator: José Lamo-Espinosa, MD Clinica Universidad de Navarra
Study Director: Felipe Prosper, MD, PhD Clínica Universidad de Navarra
Principal Investigator: Juan Blanco, MD; PhD Complejo Universitario de Salamanca
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02365142    
Other Study ID Numbers: CMM-PRGF/ART
2011-006036-23 ( EudraCT Number )
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Knee Osteoarthritis
Mesenchimal stem cell
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases