Treatment ComplicationNCT05193877
Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis:Baghdad 2022
A study testing autologous bone marrow aspirate concentrate by centrifugation in people with Treatment Complication, run by Global Stem Cell Center, Baghdad at 1 site in Iraq.
Trial summary
We present a randomized controlled trial (RCT) to assess the efficacy of autologous bone marrow aspirate concentrate BMAC of 1.8x 10 9 median cellular content in the treatment of early symptomatic knee OA. We use 2 injections 2 months apart (8). Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment Complication
- What is being tested?
- autologous bone marrow aspirate concentrate by centrifugation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 8 Feb 2022to 16 Jan 2024
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Radiological diagnosis of Osteoarthritis according to Kellgren and Lawrence Criteria stage II-III.
- Radiological grading of osteoarthritis of the knee determined by qualified radiologist using MOAKS scoring system.
- Primary osteoarthritis not responsive to conventional treatment and physiotherapy.
- A minimum pain score of 5 on an 11-point numerical scale.
- Age >55 years
Who cannot join
- Pregnancy and breast feeding.
- Knee symptom due to other condition like tumor or referred pain from lumbar spine.
- MRI confirmed displaced meniscal tear
- MRI confirmed Grade IV chondral loss.
- Previous knee surgery within the last 12 months.
- Previous intra-articular injectable therapies within the last 6 months
Show all 9Show fewer
- History of severe systemic illness.
- Active neoplasm under treatment in the last 12 months- Health conditions including known allergy to local
- Bleeding tendency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis: a Randomized Controlled Trial, Ibn-Sina Hospital, Baghdad 2022
We present a randomized controlled trial (RCT) to assess the efficacy of autologous bone marrow aspirate concentrate BMAC of 1.8x 10 9 median cellular content in the treatment of early symptomatic knee OA. We use 2 injections 2 months apart (8).
Read the detailed description
- To evaluate the efficacy of bone marrow aspirate concentrate (BMAC) therapy on pain, function and disease modification in knee osteoarthritis.
- To determine the potential of BMAC therapy to achieve disease modification, as detected through radiological examination using magnetic resonance imaging (MRI) techniques.
- Methodology:
A randomized controlled trial will be held in Ibn-Sina training hospital in Baghdad. All participants will complete written informed consent. The study will be a single centered trial.
The trial design will consist of 60 participant randomly and equally allocated to control and treatment group by simple random sampling. Participants will not be blinded to their treatment allocation. Control group will receive conventional treatment only. Intervention group will receive (2 injections) intra-articular injections of (4cc) per joint at (8 weeks' interval).
Intervention:
50 cc bone marrow aspirates concentrate after centrifugation with final volume up to 7 cc.
Assess total nucleated count and viability. Bone marrow aspirate concentrate is chosen as a source of mesenchymal stem cells, because of safe and easy procedure.
Bone marrow aspiration is done under local or general anesthesia, depending on the individual case. Around 50 cc of bone marrow is aspirated from the posterior iliac crest after proper sterilization using bone marrow aspiration needle (size according to the patient) and collected in heparinized syringes. Mononuclear cells (MNCs) are obtained by centrifugation. The isolated MNCs are checked for viability manually and confirmed on automated cell count machine.
The separated MNCs is administered intra-articularly immediately after centrifugation.
Place:
Bone marrow aspiration and centrifugation procedure is done in clean area, in operation room HEPA filtered with all instruments included. Cell count viability and flow cytometry can be sent to nearby lab.CD markers (90, 44,29,105,34).
Instruments:
Bone marrow aspiration kit, centrifuge, automated cell counter.
Sample size and sampling technique:
The conventional treatment is usually classic treatment .
Statistical analysis:
Raw data will be summarized, and presented in appropriate table. The statistical analysis will be carried out using SPSS (statistical package for social science) software version 25
- Conditions
- Treatment Complication
- Being tested
- autologous bone marrow aspirate concentrate by centrifugation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow aspirate concentrate by centrifugationProcedure or surgery
50 cc bone marrow aspirates concentrate after centrifugation with final volume up to 7 cc.
Assess total nucleated count and viability. Bone marrow aspirate concentrate is chosen as a source of mesenchymal stem cells, because of safe and easy procedure.
Bone marrow aspiration is done under local or general anesthesia, depending on the individual case. Around 50 cc of bone marrow is aspirated from the posterior iliac crest after proper sterilization using bone marrow aspiration needle (size according to the patient) and collected in heparinized syringes. Mononuclear cells (MNCs) are obtained by centrifugation. The isolated MNCs are checked for viability manually and confirmed on automated cell count machine.
The separated MNCs is administered intra-articularly immediately after centrifugation.
| Study group | Role | What they receive |
|---|---|---|
| treatment with autologous bone marrow aspirate concentrate | Active comparator | autologous bone marrow aspirate is taken under local anesthesia to be centrifuged and the concentrate given intra articularly in knee joint Receives: Procedure: autologous bone marrow aspirate concentrate by centrifugation |
| control | Sham comparator | control group given analgesics only Receives: Procedure: autologous bone marrow aspirate concentrate by centrifugation |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical
improvement in pain scale WOMAC
Measured: 6 months
Secondary outcomes (1)
radiological proof
MRI of the knee joint to monitor effect
Measured: 6 months-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start8 Feb 2022
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment ComplicationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Stem Cell Center, Baghdad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, abdulmajeed hammadi, Global Stem Cell Center, Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193877
- Sponsor's protocol ID
- Ibn-sina protocol
- Status last verified
- Jan 2024
- First submitted
- 24 Dec 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis: a Randomized Controlled Trial, Ibn-Sina Hospital, Baghdad 2022
- ClinicalTrials.gov ID
- NCT05193877
- Acronym / sponsor ID
- Ibn-sina protocol
- Conditions
- Treatment Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Global Stem Cell Center, BaghdadIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 18 Jan 2022 (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.
We present a randomized controlled trial (RCT) to assess the efficacy of autologous bone marrow aspirate concentrate BMAC of 1.8x 10 9 median cellular content in the treatment of early symptomatic knee OA. We use 2 injections 2 months apart (8).
Detailed description
- To evaluate the efficacy of bone marrow aspirate concentrate (BMAC) therapy on pain, function and disease modification in knee osteoarthritis.
- To determine the potential of BMAC therapy to achieve disease modification, as detected through radiological examination using magnetic resonance imaging (MRI) techniques.
- Methodology:
A randomized controlled trial will be held in Ibn-Sina training hospital in Baghdad. All participants will complete written informed consent. The study will be a single centered trial.
The trial design will consist of 60 participant randomly and equally allocated to control and treatment group by simple random sampling. Participants will not be blinded to their treatment allocation. Control group will receive conventional treatment only. Intervention group will receive (2 injections) intra-articular injections of (4cc) per joint at (8 weeks' interval).
Intervention:
50 cc bone marrow aspirates concentrate after centrifugation with final volume up to 7 cc.
Assess total nucleated count and viability. Bone marrow aspirate concentrate is chosen as a source of mesenchymal stem cells, because of safe and easy procedure.
Bone marrow aspiration is done under local or general anesthesia, depending on the individual case. Around 50 cc of bone marrow is aspirated from the posterior iliac crest after proper sterilization using bone marrow aspiration needle (size according to the patient) and collected in heparinized syringes. Mononuclear cells (MNCs) are obtained by centrifugation. The isolated MNCs are checked for viability manually and confirmed on automated cell count machine.
The separated MNCs is administered intra-articularly immediately after centrifugation.
Place:
Bone marrow aspiration and centrifugation procedure is done in clean area, in operation room HEPA filtered with all instruments included. Cell count viability and flow cytometry can be sent to nearby lab.CD markers (90, 44,29,105,34).
Instruments:
Bone marrow aspiration kit, centrifuge, automated cell counter.
Sample size and sampling technique:
The conventional treatment is usually classic treatment .
Statistical analysis:
Raw data will be summarized, and presented in appropriate table. The statistical analysis will be carried out using SPSS (statistical package for social science) software version 25
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- double blind
| Arm | Type | Receives |
|---|---|---|
| treatment with autologous bone marrow aspirate concentrate | Active comparator | Procedure: autologous bone marrow aspirate concentrate by centrifugationautologous bone marrow aspirate is taken under local anesthesia to be centrifuged and the concentrate given intra articularly in knee joint |
| control | Sham comparator | Procedure: autologous bone marrow aspirate concentrate by centrifugationcontrol group given analgesics only |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiological diagnosis of Osteoarthritis according to Kellgren and Lawrence Criteria stage II-III.
Key exclusion criteria (9 listed)
- Pregnancy and breast feeding.
- Knee symptom due to other condition like tumor or referred pain from lumbar spine.
- MRI confirmed displaced meniscal tear
- MRI confirmed Grade IV chondral loss.
- Previous knee surgery within the last 12 months.
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 concentrate by centrifugation50 cc bone marrow aspirates concentrate after centrifugation with final volume up to 7 cc. Assess total nucleated count and viability. Bone marrow aspirate concentrate is chosen as a source of mesenchymal stem cells, because of safe and easy procedure. Bone marrow aspiration is done under local or general anesthesia, depending on the individual case. Around 50 cc of bone marrow is aspirated from the posterior iliac crest after proper sterilization using bone marrow aspiration needle (size according to the patient) and collected in heparinized syringes. Mononuclear cells (MNCs) are obtained by centrifugation. The isolated MNCs are checked for viability manually and confirmed on automated cell count machine. The separated MNCs is administered intra-articularly immediately after centrifugation. | Procedure or surgery | control, treatment with autologous bone marrow aspirate concentrate |
Primary outcome
clinical
Time frame: 6 months
improvement in pain scale WOMAC
1 secondary outcome
radiological proof
Time frame: 6 months-1 year
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 17 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 by centrifugation in people with Treatment Complication, run by Global Stem Cell Center, Baghdad 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 5 inclusion and 9 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 17 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
clinical (time frame: 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 17 Jan 2024.