"One-step" Bone Marrow Mononuclear Cell Transplantation in Talar Osteochondral Lesions (BMDC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Istituto Ortopedico Rizzoli
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT02005861
First received: November 5, 2013
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

BACKGROUND Osteochondral lesions are defects of the cartilaginous surface and underlying subchondral bone of the talar dome.

The use of concentrated bone marrow derived cells has been gaining successful results with arthroscopic implantation, since it is possible to transplant not only mesenchymal stem cells but also accessory cells that support angiogenesis and vasculogenesis by producing several growth factors. This suggests no cell selection and expansion in the laboratory may be required and consequently the transplant can be performed in one operative procedure.

OBJECTIVES Objective of this project is to identify the critical points of the regenerative treatment of osteochondral lesions of the ankle, in order to develop a standard and predictable procedure able to overcome the drawbacks of the previous techniques. In particular the expansion of knowledge in the etiopathogenic of cartilage lesions will lead to an identification of factors associated that may influence the prognosis.

METHODS Our program is to evaluate and follow 140 new patients with focal osteochondral lesion of the talus. The surgical procedure will be executed as following: the day before the surgery 120 ml of venous blood will be collected for the platelet gel production. The day of the surgery 60 ml of bone marrow will be aspirate from the posterior iliac crest and concentrated directly in the operating room by centrifugation, in order to obtain 6 mL of concentrate containing nucleated cells.

After the bone marrow harvesting phase, a standard ankle arthroscopy will be performed. The scaffold will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape.

In case of deep lesions (more than 7 mm) demineralised bone matrix will be use to close the defect, before placing the scaffold. After the scaffold implantation platelet gel will be sprayed on the top of implant, in order to provide extra growth factors and to improve the stability of the implant.

All patients will be examined clinically preoperatively, at 3, 6, 12, 24 and 36 months and at maximum follow-up. Different score scales will be used to objectivate the clinical results (AOFAS, SF-36, VAS). X-rays and MRI scan will be also taken preoperatively, and MRI will be executed at 12, 24 and 36 months of follow-up. In particular, a new qualitative MRI called T2 mapping will be performed at 24 months.

EXPECTED RESULTS We expect to highlight the effectiveness of the arthroscopic bone marrow derived cells (BMDCs) transplantation in a long term follow up study, with particular attention to identify the patient population that can gain the maximum benefit from this treatment, avoiding expensive and unnecessary procedures that too often are performed.


Condition Intervention Phase
Osteochondritis
Genetic: bone marrow derived cells transplantation on collagen scaffold
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "One-step" Bone Marrow Mononuclear Cell Transplantation in Talar Osteochondral Lesions

Further study details as provided by Istituto Ortopedico Rizzoli:

Primary Outcome Measures:
  • American Orthopaedic Foot and Ankle Society hindfoot score [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
    American Orthopaedic Foot and Ankle Society hindfoot score will be used to assess the quality of life of the patients with a minimum score of 0 and a maximum of 100.


Secondary Outcome Measures:
  • T2 mapping MRI value [ Time Frame: 12 and 24 months after surgery ] [ Designated as safety issue: No ]
    MRI will be performed with T2 mapping sequences and T2 values will be recorded as indicator of quality through water content of the regenerated tissue.


Estimated Enrollment: 140
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bone marrow derived cells transplantation

The surgical procedure will be executed as following: the day before the surgery 120 ml of venous blood will be collected for the platelet gel production performed with an automatic method by Unit 5. The day of the surgery, 60 ml of bone marrow will be aspirate from the posterior iliac crest of the patient and concentrated in order to obtain 6 mL of concentrate bone marrow (CBM) containing nucleated cells. After the bone marrow harvesting phase, a standard ankle arthroscopy will be performed, with the patient in the supine position. The lesion will be detected and cleaned.

An equine collagen type 1 scaffold (IOR-G1, Novagenit, Mezzolombardo, TN, Italy) will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape to fit the lesion.

After the scaffold implantation 2 ml of platelet gel will be loaded on the top of implant, in order to provide growth factors and to improve the stability of the implant.

Genetic: bone marrow derived cells transplantation on collagen scaffold

120 ml of venous blood will be collected for the platelet gel production. The day of the surgery, 60 ml of bone marrow will be aspirate from the posterior iliac crest and concentrated. a standard ankle arthroscopy will be performed, with the patient in the supine position. The lesion will be detected and cleaned.

An equine collagen type 1 scaffold (IOR-G1, Novagenit, Mezzolombardo, TN, Italy) will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape to fit the lesion.

After the scaffold implantation 2 ml of platelet gel will be loaded on the top of implant, in order to provide growth factors and to improve the stability of the implant.

Other Names:
  • the bone marrow derived cells transplantation will be performed with kit IOR-G1, Novagenit, Mezzolombardo, TN, Italy, that includes a collagen scaffold
  • Autologous platelet gel will be implanted on the scaffold

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Osteochondral lesions of the talar dome
  • Presence of lesion classified as ICRS grade III or IV
  • size of the lesion >1.5 cm2
  • age <50 years

Exclusion Criteria:

  • Presence of osteoarthritis
  • presence of concomitant tibial lesion
  • presence of ankle malalignment
  • presence of ankle instability
  • presence of rheumatic diseases
  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: NCT02005861

Contacts
Contact: Sandro Giannini, Prof 0516366669 ext +39 giannini@ior.it

Locations
Italy
I Clinic, Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Contact: Sandro Giannini, Prof    0516366669    giannini@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Sandro Giannini, Prof Rizzoli Orthopaedic Institute, Bologna, Italy
  More Information

No publications provided

Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT02005861     History of Changes
Other Study ID Numbers: 0008310, 11.03.2013
Study First Received: November 5, 2013
Last Updated: December 6, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Ortopedico Rizzoli:
osteochondral lesion
talus
ankle
cartilage repair

Additional relevant MeSH terms:
Osteochondritis
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 18, 2014