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

NCT05193877 | Completed DMC

• 1 other identifier: Ibn-sina protocol
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Treatment Complication

Outcome Measures

Primary Outcomes (1)

• clinical

  improvement in pain scale WOMAC

  6 months

Secondary Outcomes (1)

• radiological proof

  6 months-1 year

Study Arms (2)

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

Procedure: autologous bone marrow aspirate concentrate by centrifugation

control

SHAM COMPARATOR

control group given analgesics only

Procedure: autologous bone marrow aspirate concentrate by centrifugation

Interventions

autologous bone marrow aspirate concentrate by centrifugation PROCEDURE

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.

control; treatment with autologous bone marrow aspirate concentrate

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Global Stem Cell Center, Baghdad: lead

Study Sites (1)

Ministry of Health

Baghdad, 964, Iraq

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: global stem cell center baghdad

Model Details: double blind

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 18, 2022
• Study Start: February 8, 2022
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)