Anterior Cruciate Ligament TearNCT06353503
Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.
A study testing autologous bone marrow aspirate concentrate in people with Anterior Cruciate Ligament Tear, run by abdulmajeed hammadi at 1 site in Iraq.
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… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- autologous bone marrow aspirate concentrate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 2 Apr 2024to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- autologous bone marrow aspirate concentrate
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow aspirate concentrateProcedure or surgery
local knee joint injection of autologous bone marrow
| Study group | Role | What they receive |
|---|---|---|
| bone marrow injection | Experimental | intra articular injection of autologous bone marrow aspirate concentrate 4cc in the injured knee under local anesthesia and ultrasound guide Receives: Procedure: autologous bone marrow aspirate concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional recovery by clinical assessments of the ACL and overall knee joint stability.
lachman test
Measured: every 12 weeks till 6 months
Secondary outcomes (1)
magnetic resonance imaging of the knee joint
to assess the degree of anterior cruciate ligament tear
Measured: 6 months from starting recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start2 Apr 2024
- Primary completion10 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single armed study open label
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- abdulmajeed hammadi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, abdulmajeed hammadi, Global Stem Cell Center, Baghdad
- Investigators
- abdulmajeed a hammadi, MD, Study director, clinical stem cell studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353503
- Sponsor's protocol ID
- KAZ
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Autologous Bone Marrow Aspirate Concentrate to Treat Complete Anterior Cruciate Ligament Tear.
- ClinicalTrials.gov ID
- NCT06353503
- Acronym / sponsor ID
- KAZ
- Conditions
- Anterior Cruciate Ligament Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- abdulmajeed hammadiIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single armed study open label
| Arm | Type | Receives |
|---|---|---|
| bone marrow injection | Experimental | Procedure: autologous bone marrow aspirate concentrateintra articular injection of autologous bone marrow aspirate concentrate 4cc in the injured knee under local anesthesia and ultrasound guide |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous bone marrow aspirate concentratelocal knee joint injection of autologous bone marrow | Procedure or surgery | bone marrow injection |
Primary outcome
Functional recovery by clinical assessments of the ACL and overall knee joint stability.
Time frame: every 12 weeks till 6 months
lachman test
1 secondary outcome
magnetic resonance imaging of the knee joint
Time frame: 6 months from starting recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abdulmajeed a hammadi, MD study director
clinical stem cell studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous bone marrow aspirate concentrate in people with Anterior Cruciate Ligament Tear, run by abdulmajeed hammadi at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recovery by clinical assessments of the ACL and overall knee joint stability. (time frame: every 12 weeks till 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.