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Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis:Baghdad 2022

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ClinicalTrials.gov Identifier: NCT05193877
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : March 21, 2022
Sponsor:
Information provided by (Responsible Party):
zaid husein ali, Global Stem Cell Center, Baghdad

Brief 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).

Condition or disease Intervention/treatment Phase
Treatment Complication Procedure: autologous bone marrow aspirate concentrate by centrifugation Not Applicable

Detailed Description:
  1. To evaluate the efficacy of bone marrow aspirate concentrate (BMAC) therapy on pain, function and disease modification in knee osteoarthritis.
  2. To determine the potential of BMAC therapy to achieve disease modification, as detected through radiological examination using magnetic resonance imaging (MRI) techniques.
  3. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis: a Randomized Controlled Trial, Ibn-Sina Hospital, Baghdad 2022
Actual Study Start Date : February 8, 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: treatment with autologous bone marrow aspirate concentrate
autologous bone marrow aspirate is taken under local anesthesia to be centrifuged and the concentrate given intra articularly in knee joint
Procedure: autologous bone marrow aspirate concentrate by centrifugation

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.


Sham Comparator: control
control group given analgesics only
Procedure: autologous bone marrow aspirate concentrate by centrifugation

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.





Primary Outcome Measures :
  1. clinical [ Time Frame: 6 months ]
    improvement in pain scale WOMAC


Secondary Outcome Measures :
  1. radiological proof [ Time Frame: 6 months-1 year ]
    MRI of the knee joint to monitor effect



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of severe systemic illness.
  • Active neoplasm under treatment in the last 12 months- Health conditions including known allergy to local
  • Bleeding tendency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05193877


Contacts
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Contact: abdulmajeed hammadi, MD +9647902268105 majeed51578@yahoo.co.uk

Locations
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Iraq
Ibn Sina Recruiting
Baghdad, Iraq, 964
Contact: mutlaq, master    9647701686515    alsafarsaif@gmail.com   
Sponsors and Collaborators
zaid husein ali
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Responsible Party: zaid husein ali, global stem cell group, Global Stem Cell Center, Baghdad
ClinicalTrials.gov Identifier: NCT05193877    
Other Study ID Numbers: Ibn-sina protocol
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases