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NCT06353503 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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