Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study

Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03110666

Acronym

IOC-target

Enrollment

Registered

2017-04-12

Start date

2016-11-14

Completion date

2022-05-31

Last updated

2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis ,, bone marrow aspirate, injections

Brief summary

This pilot study will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of autologous concentrated bone marrow aspirate at the bone-cartilage interface via percutaneous.

Detailed description

This pilot study (N=30) patients will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of bone marrow concentrate (BMC),obtained from the Bone Marrow Aspirate Concentration System (BioCUE) at the bone-cartilage interface via percutaneous injections. The PerFuse system will also be evaluated to determine if it can be used to deliver the BMC to the osseous sites. Follow-up is 1, 3, 6, 12, and 24 months.

Interventions

BIOLOGICALInjection of autologous concentrated bone marrow aspirate

Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

autologous concentrated bone marrow aspirate

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* age ranging from 40 to 75 * Osteoarthritis of the medial or lateral compartment (2-3-4 grade according to the Kellgren-Lawrence score); * Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs,hyaluronic acid,platelet-rich plasma and corticosteroids injections); * Signature of informed consent.

Exclusion criteria

* Patients with trauma in the 6 months prior to the intervention; * Patients with malignancies; * Patients with rheumatic diseases; * Patients with diabetes; * Patients suffering from metabolic disorders of the thyroid; * Patients being abuse of alcohol, drugs or medications; * Body Mass Index\> 35;

Design outcomes

Primary

Measure	Time frame	Description
improvement of the International Knee Documentation Committee (IKDC) subjective score	Time Frame: 1,3,6, 12, 24 months evaluation	(International Knee Documentation Committee)

Secondary

Measure	Time frame	Description
improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)	Time Frame: 1,3,6, 12, 24 months evaluation	(Knee Injury and osteoarthritis Outcome Score)
evaluation of WORMS score for MRI	Time Frame: 6, 12, 24 months evaluation	MRI score

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026