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NCT Number: NCT06353503

Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.

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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Key information

Conditions

Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

  • 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.

  • Individuals with a history of malignancy, due to the potential risks associated with growth factors present in BMAC.
  • Critically ill patients or those with comorbidities

Treatment and study plan

Autologous Bone Marrow Aspirate Concentrate

Procedure

local knee joint injection of autologous bone marrow

Primary outcomes

  1. Functional recovery by clinical assessments of the ACL and overall knee joint stability.

    Time frame: every 12 weeks till 6 months

    lachman test

Secondary outcomes

  1. magnetic resonance imaging of the knee joint

    Time frame: 6 months from starting recruitment

    to assess the degree of anterior cruciate ligament tear

Study contacts

Contact information is provided by the study sponsor or research team.

abdulmajeed A hammadi, MD

CONTACT

[email protected]

+9647902268105

khalil J kareem, MD

CONTACT

[email protected]

+9647803977072

Sponsors and collaborators

Lead sponsor

abdulmajeed hammadi

Industry

Registry information

Official study title

Using Autologous Bone Marrow Aspirate Concentrate to Treat Complete Anterior Cruciate Ligament Tear.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Aug 7, 2025

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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