Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2026-09-27

Brief Summary

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A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia.

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Detailed Description

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The anterior cruciate ligament (ACL) is key to the functional stability of the knee joint and is highly susceptible to injury, especially in athletes engaged in high-impact sports. Conventional treatment for partial tears may involve conservative management; however, complete tears often necessitate surgical reconstruction. In seeking alternative treatments, this study investigates the potential of bone marrow aspirate concentrate BMAC-a regenerative medicine approach-to promote healing and restore functionality to completely torn ACLs. The regenerative properties of BMAC, attributed to the presence of stem cells and growth factors, may facilitate ligament repair and regeneration. the team aim treating 1st and 2nd degree anterior cruciate ligament tear without retraction.

Conditions

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Anterior Cruciate Ligament Tear

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single armed study open label

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bone marrow injection

intra articular injection of autologous bone marrow aspirate concentrate 4cc in the injured knee under local anesthesia and ultrasound guide

Group Type EXPERIMENTAL

autologous bone marrow aspirate concentrate

Intervention Type PROCEDURE

local knee joint injection of autologous bone marrow

Interventions

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autologous bone marrow aspirate concentrate

local knee joint injection of autologous bone marrow

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1- Confirmed diagnosis of complete or partial ACL tear via clinical examination and imaging studies.

2\. Aged between 20 and 55 years, to encompass the typical age range of patients with sports-related ACL injuries.

Exclusion Criteria

1- Patients with a history of bleeding disorders, as this could complicate the aspiration and injection procedures.

2\. Individuals with a history of malignancy, due to the potential risks associated with growth factors present in BMAC.

3\. Critically ill patients or those with comorbidities

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No