Clinical trial NCT03410355: Bone Marrow Aspirate Concentrate Use in Hip Osteoarthritis
Official title: The Use of Bone Marrow Aspirate Concentrate in the Context of Hip Osteoarthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of combined Bone marrow aspirate concentrate (BMAC) and Platelet Rich Plasma (PRP) action after a single hip intraarticular injection to young symptomatic patients with primary radiologic stage of hip OA (Kellgren-Lawrence grade I or II) compared to a control local anesthetic with cortisone injection group of patients. The hypothesis is that the patients with hip OA will benefit more and for longer from OA symptoms in the BMAC and PRP group rather than in the group of local anaesthetic and cortisone. Furthermore, this study could be valuable in determining the safety and effectiveness of the BMAC and PRP combined injection for early low grade hip OA in young active patients who are neither good candidates for total hip replacement nor preservative hip surgery.

Detailed description: The protocol will be applied to a blinded randomized controlled study. Patients who fit the inclusion criteria and have consented to the trial, will be randomized to receive a single injection of BMAC with PRP or local anesthetic with cortisone.

Pre-Injection Procedures:

Patients will receive a clinical evaluation where they will complete the HHS, the WOMAC score, the VR-12 form, VAS score, and the two functional assessment tests to assess pain and function prior to the injection. The two functional assessments will be performed by the blinded researcher. Following the evaluation, the patients will receive an intra-articular hip injection.

Injection Procedures:

Control group: In the second group of patients, an intraarticular injection of 1cm3 with 80mg of methylprednisolone combined with 3cm3 of 0.25% bupivacaine will be performed in the same manner with the first group.

Experimental group: In the first group, patients will be placed on an office procedure under local anesthesia. The investigators will harvest 60 cm3 of bone marrow from posterior iliac crest and centrifuged obtaining approximately 3 cm3 of autologous bone marrow-mesenchymal stem cells concentrate. At the same time, 60cm3 of peripheral blood will be taken and centrifugated once, to obtain approximately 3 cm3 of PRP. After activation of platelet rich plasma cells they will be mixed in one syringe with the concentrated BMaC and both will be injected in the hip joint under ultrasound. In all cases four samples of 0.2cm3 will be collected, one with patient's whole blood, one with the PRPs final mixture, one with whole bone marrow aspirate, and one with the BMaCs final mixture, and will be sent to the NSHA Hematology Laboratory for cell quantification. The leukocyte counts and differential (neutrophils, monocytes, lymphocytes, eosinophils and basophils) as well as thrombocyte counts in all samples will be determined using Automated Hematology Analyzer (Sysmex). Percentages of mature and immature leukocytes in the bone marrow aspirate and BMaC samples will be determined by standard morphologic examination using slides prepared with the Wright's stain. CD34+ stem cell enumeration in the bone marrow aspirate sample and BMaC will be performed by flow cytometry (Canto II Analyser).The concentration factor of PRP will be calculated from the quotient of the thrombocyte count in whole blood and in PRP. Additionally, IGF-I, VEGF, TGF-b, bFGF, HGF and PDGF will be quantified in serum or plasma and in PRP using commercially available ELISA kits (QuantikineH, ELISA KITS, R\&D Systems, USA).

Post-Injection Procedures:

Clinic visits will occur at 6, 12, 24, and 48 weeks post-injection to perform clinical evaluations with outcome measures of the patients. All collected data will be statistically analyzed to check the effect of BMAC and PRP intraarticular hip injections in young patients with early OA. The investigators will also document the activity level of all participants (type of sport or activity participated in and the intensity and volume of participation) and correlate it with the outcomes.

Eligibility criteria: Inclusion Criteria:

* Age \<60 years old
* BMI of \<40 kg/m2
* Able to walk 50m unaided and not confined to a wheel chair
* Unilateral hip pain and radiographically and arthroscopically verified OA of the hip within the last 6 months (Kellgren-Lawrence grade I or II)
* HHS of less than 80
* Ability to understand the informed consent and participation instructions Attempted to use over the counter therapy without relief
* Able to participate for the entire protocol study period
* Able to follow physicians directions

Exclusion Criteria:

* Clinically significant OA in the contralateral hip
* Clinically significant pain in any other joint
* Have had intra-articular BMAC and or PRP injection within the preceding six months in the study hip
* Have had intra-articular steroid injection within the preceding three months in the study hip
* Have had previous surgical procedures on the affected hip within the preceding 6 months
* Have had a serious injury to the study hip within the previous 3 months
* Have had a serious psychological or medical condition that would interfere with their involvement
* Have had treatment with pain medications other than Tylenol and the drug remains in their system at the baseline or first study visit
* Have used of opioids other than weak opioids for OA pain more than 3 days/week within the last month
* Have used of systemic glucocorticoids (excluding inhaled steroids) within the preceding 3 months
* Treatment started with glucosamine/chondroitin sulfate or if the dosing has not been stable in the previous three months
* Has had a history of septic arthritis, skin infection or disease in the region of the injection site
* Currently using an anticoagulant excluding Aspirin 325 mg/day
* Uncontrolled diabetes
* Has any medical condition the principal investigator believes deems the patient unsuitable for the study
* Has any pathology of lumbar spine, sacroiliac (SI) joints, neuropathic or extra-articular hip pain
* Has a history of alcohol or drug abuse within the six months prior to enrolment in the study
* Has had a diagnosis of rheumatoid arthritis
* Has had a diagnosis of ankylosing spondylitis
* Has had a diagnosis of psoriatic arthritis
* Has had a diagnosis of reactive arthritis
* Has had a diagnosis of gout
* Has had a diagnosis of any connective tissue disease.

Primary outcomes:
measure: Functional Benefit and Pain Level Changes using iHOT33 Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Functional Benefit and Pain level Changes using the modified Harris Hip Score (HHS)
timeFrame: 6 months
measure: Functional Benefit and Pain level Changes using the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months
measure: Burden of Disease and Quality of Life Changes using the Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: 6 months
measure: Pain Changes using the Visual Analogue Scale (VAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Ivan Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: