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Completed

NCT Number: NCT02123368

Treatment of Knee Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells

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

Patients and methods

Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:

1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose. 2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 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 Hiaurónico Acid ( Hyalone®). 3. Group C : High dose of MSCs. 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 Hiaurónico Acid (Hyalone®).

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Traumatology department. Complejo Hospitalario de Salamanca, Salamanca, Castille and León, Spain

Loading trial locations.

About this study

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

Patients and methods

Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:

  • Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
  • Group B: Low Dosage of MSCs . Intra-articular injection of 10 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 Hiaurónico Acid ( Hyalone®).
  • Group C : High dose of MSCs. 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 Hiaurónico Acid (Hyalone®).

The autologous mesenchymal stem cells are obtained from the iliac crest and cultured ex vivo under local anesthesia and sedation.

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:

Inclusion criteria

  • Males and females between 50 and 80 year old.
  • 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.
  • Allergy to hyaluronic acid or poultry proteins.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females between 50 and 80 year old.
  • 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.
  • Allergy to hyaluronic acid or poultry proteins.

Treatment and study plan

Hyaluronic acid

Drug

Single intraarticular injection of Hyaluronic acid (Hyal One)

Other names: HyalOne

10 million Bone marrow mesenchimal stem cells

Biological

10 million of Bone marrow mesenchimal stem cells

100 million Bone marrow mesenchimal stem cells

Biological

100 million of Bone marrow mesenchimal stem cells

Primary outcomes

  1. Baseline Visual analogue scale (VAS)

    Time frame: prior to the initial dose on day 1

    Baseline Visual analogue scale (VAS)

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

    Time frame: Prior to the intervention on 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: Prior to the intervention on day 1

    Prior to the intervention on day 1 Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).

  4. Baseline SF-36 value

    Time frame: Prior to the intervention on day 1

    Prior to the intervention on day 1 SF-36 value

  5. Baseline euroquol 5D value

    Time frame: Prior to the intervention on day 1

    Pretreatment euroquol 5D value

  6. Baseline Lequesne index

    Time frame: Prior to the intervention on day 1

    Prior to the intervention on day 1 Lequesne index

  7. Baseline femorotibial distance

    Time frame: Prior to the intervention

    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

    During the follow up

  9. Visual analogue scale (VAS) at on 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

  17. Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month

    Time frame: 1 month

    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month

  18. Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 3 month

    Time frame: 3 months

    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month

  19. Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month

    Time frame: 6 months

    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month

  20. Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months

    Time frame: 12 months

    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months

  21. SF-36 value at 1 month

    Time frame: 1 month

    SF-36 value

  22. SF 36 value at 3 months

    Time frame: 3 months

    SF 36 value at 3 months

  23. SF 36 value at 6 months

    Time frame: 6 months

    SF 36 value at 6 months

  24. SF 36 value at 12 months

    Time frame: 12 months

    SF 36 value at 12 months

  25. Euroquol 5D value at 1 month

    Time frame: 1 MOnth

    Euroquol 5D value at 1 month

  26. Euroquol 5D value at 3 months

    Time frame: 3 months

    Euroquol 5D value at 3 months

  27. Euroquol 5D value at 6 months

    Time frame: 6 months

    Euroquol 5D value at 6 months

  28. Euroquol 5D value at 12 months

    Time frame: 12 months

    Euroquol 5D value at 12 months

  29. Lequesne index at 1 month

    Time frame: 1 month

    Lequesne index at 1 month

  30. Lequesne index at 3 months

    Time frame: 3 months

    Lequesne index at 3 months

  31. Lequesne index at 6 months

    Time frame: 6 months

    Lequesne index at 6 months

  32. Lequesne index at 12 months

    Time frame: 12 months

    Lequesne index at 12 months

  33. Femorotibial distance at 6 months

    Time frame: 6 months

    Femorotibial distance at 6 months

  34. Femorotibial distance at 12 months

    Time frame: 12 months

    Femorotibial distance at 12 months

  35. Baseline MRI WORMS protocol

    Time frame: Prior to the intervention

    Prior to the intervention MRI WORMS protocol

  36. MRI WORMS protocol score at 6 months

    Time frame: 6 months

    MRI WORMS protocol score at 6 months

  37. MRI WORMS protocol score at 12 months

    Time frame: 12 months

    MRI WORMS protocol score at 12 months

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 25, 2014
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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