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

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).

Study Overview

• Status: Completed
• Conditions: Treatment Complication
• Intervention / Treatment: Procedure: autologous bone marrow aspirate concentrate by centrifugation

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 964
    • Ministry of health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical	improvement in pain scale WOMAC	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiological proof	MRI of the knee joint to monitor effect	6 months-1 year

Collaborators and Investigators

• Sponsor: Global Stem Cell Center, Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): January 16, 2024
• Study Completion (Actual): January 16, 2024

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Ibn-sina protocol

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