Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353503
• Other study ID #: KAZ
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: September 27, 2024

Study information

• Verified date: April 2024
• Source: Global Stem Cell Center, Baghdad
• Contact: abdulmajeed A hammadi, MD
• Phone: +9647902268105
• Email: majeed51578[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 27, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

Intervention

Procedure:
• autologous bone marrow aspirate concentrate
local knee joint injection of autologous bone marrow

Locations

Country	Name	City	State
Iraq	Ministry of Health	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
abdulmajeed hammadi

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional recovery by clinical assessments of the ACL and overall knee joint stability.	lachman test	every 12 weeks till 6 months
Secondary	magnetic resonance imaging of the knee joint	to assess the degree of anterior cruciate ligament tear	6 months from starting recruitment