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Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.

A

abdulmajeed hammadi

Status

Enrolling

Conditions

Anterior Cruciate Ligament Tear

Treatments

Procedure: autologous bone marrow aspirate concentrate

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 estimated patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

  1. 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.

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

  2. Critically ill patients or those with comorbidities

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

bone marrow injection
Experimental group
Description:
intra articular injection of autologous bone marrow aspirate concentrate 4cc in the injured knee under local anesthesia and ultrasound guide
Treatment:
Procedure: autologous bone marrow aspirate concentrate

Trial contacts and locations

1

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Central trial contact

abdulmajeed A hammadi, MD; khalil J kareem, MD

Data sourced from clinicaltrials.gov

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