NCT02365142

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:

  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P50-P75 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

July 18, 2014

Last Update Submit

October 23, 2017

Conditions

Knee Osteoarthritis

Keywords

Knee OsteoarthritisMesenchimal stem cellOsteoarthritis

Outcome Measures

Primary Outcomes (16)

  • Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS)

    Baseline Visual analogue scale (VAS) prior to the initial dose on day 1

    Day 1

  • Baseline value of knee injury and osteoarthritis outcome score (Koos).

    Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).

    Day 1

  • Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).

    Universities Osteoarthritis Index score (WOMAC).

    Day 1

  • Baseline SF-36 value

    Baseline SF-36 value

    Day 1

  • Baseline euroquol 5D value

    Pretreatment euroquol 5D value

    Day 1

  • Baseline Lequesne index

    Prior to the intervention on day 1 Lequesne index

    Day 1

  • Baseline femorotibial distance

    Prior to the intervention femoritibial distance on rosenberg x-ray view

    Day 1

  • 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

    Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events During the follow up

    Follow up (up to 12 months)

  • Visual analogue scale (VAS) at 1 month

    Visual analogue scale (VAS) at on month

    1 month

  • Visual analogue scale (VAS) at 3 months

    Visual analogue scale (VAS) at 3 months

    3 months

  • Visual analogue scale (VAS) at 6 months

    Visual analogue scale (VAS) at 6 months

    6 months

  • Visual analogue scale (VAS) at 12 months

    Visual analogue scale (VAS) at 12 months

    12 months

  • Value of knee injury and osteoarthritis outcome score (Koos) at 1 month

    Value of knee injury and osteoarthritis outcome score (Koos) at 1 month

    1 month

  • Value of knee injury and osteoarthritis outcome score (Koos) at 3 month

    Value of knee injury and osteoarthritis outcome score (Koos) at 3 month

    3 Months

  • Value of knee injury and osteoarthritis outcome score (Koos) at 6 month

    Value of knee injury and osteoarthritis outcome score (Koos) at 6 month

    6 months

  • Value of knee injury and osteoarthritis outcome score (Koos) at 12 months

    Value of knee injury and osteoarthritis outcome score (Koos) at 12 months

    12 months

Study Arms (2)

Platelet Rich Plasma (PRGF)

ACTIVE COMPARATOR

Platelet Rich plasma (PRGF) 3 intraarticular onjections sepataded by 7 days.

Biological: Platelet Rich plasma (PRGF)

BMMSC with Platelet Rich Plasma (PRGF)

ACTIVE COMPARATOR

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 cellsBiological: Platelet Rich plasma (PRGF)

Interventions

100 million Bone marrow mesenchimal stem cellsBIOLOGICAL

100 million Bone marrow mesenchimal stem cells with PRGF

BMMSC with Platelet Rich Plasma (PRGF)
Platelet Rich plasma (PRGF)BIOLOGICAL

3 injections of PRGF

BMMSC with Platelet Rich Plasma (PRGF)Platelet Rich Plasma (PRGF)

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Patients with a history of allergy to penicillin or streptomycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Departamento Cirugía Ortopédica y Traumatología. Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

  • Lamo-Espinosa JM, Blanco JF, Sanchez M, Moreno V, Granero-Molto F, Sanchez-Guijo F, Crespo-Cullel I, Mora G, San Vicente DD, Pompei-Fernandez O, Aquerreta JD, Nunez-Cordoba JM, Vitoria Sola M, Valenti-Azcarate A, Andreu EJ, Del Consuelo Del Canizo M, Valenti-Nin JR, Prosper F. Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis. J Transl Med. 2020 Sep 18;18(1):356. doi: 10.1186/s12967-020-02530-6.

    PMID: 32948200DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • José Lamo-Espinosa, MD

    Clinica Universidad de Navarra

    PRINCIPAL INVESTIGATOR

  • Felipe Prosper, MD, PhD

    Clínica Universidad de Navarra

    STUDY DIRECTOR

  • Juan Blanco, MD; PhD

    Complejo Universitario de Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

February 18, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 24, 2017

Record last verified: 2017-10

Locations

ES(2)