Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.

NCT06353503 | Recruiting

• 1 other identifier: KAZ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (1)

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

  lachman test

  every 12 weeks till 6 months

Secondary Outcomes (1)

• magnetic resonance imaging of the knee joint

  6 months from starting recruitment

Study Arms (1)

bone marrow injection

EXPERIMENTAL

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

Procedure: autologous bone marrow aspirate concentrate

Interventions

autologous bone marrow aspirate concentrate PROCEDURE

local knee joint injection of autologous bone marrow

bone marrow injection

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• abdulmajeed hammadi: lead

Study Sites (1)

Ministry of Health

Baghdad, 964, Iraq

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• abdulmajeed a hammadi, MD

  clinical stem cell studies

  STUDY DIRECTOR

Central Study Contacts

abdulmajeed A hammadi, MD

CONTACT

+9647902268105; majeed51578@yahoo.co.uk

khalil J kareem, MD

CONTACT

+9647803977072; khaliljumakareem69@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: GSCCBaghdad

Model Details: single armed study open label

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): September 27, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)