Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.

April 2, 2024 updated by: abdulmajeed hammadi

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bone marrow injection
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
local knee joint injection of autologous bone marrow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional recovery by clinical assessments of the ACL and overall knee joint stability.
Time Frame: every 12 weeks till 6 months
lachman test
every 12 weeks till 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
magnetic resonance imaging of the knee joint
Time Frame: 6 months from starting recruitment
to assess the degree of anterior cruciate ligament tear
6 months from starting recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

abdulmajeed hammadi

Investigators

  • Study Director: abdulmajeed a hammadi, MD, clinical stem cell studies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

September 27, 2024

Study Completion (Estimated)

September 27, 2024

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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