Clinical trial NCT01985633: Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee
Official title: Autologous Bone Marrow Derived Mesenchymal Stem Cells Enhanced With Platelet Rich Plasma Versus Platelet Rich Plasma In Osteoarthritis Knee:A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
stem cells
Platelet gel
Functional outcome
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
Collaborators: name: Post Graduate Institute of Medical Education and Research, Chandigarh
First posted: 2013-11-15
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is one of the most common joint diseases.This disease commonly develops in the weight bearing joints of the lower limbs, such as the knee and hip joints. Osteoarthritis is considered a chronic degenerative disorder that is characterized by a loss of articular cartilage. Pathogenesis can involve all of the major articular tissues including cartilage, synovial membrane, subchondral bone and other connective tissues such as ligaments and tendons3. There is no effective therapy available today that alters the pathobiologic course of the disease.In view of vast role of platelet derived growth factors, mesenchymal cells and its safety, this prospective clinical trial is designed in an attempt to compare the efficacy of mesenchymal stem cells enhanced with platelet rich plasma in early stages of knee osteoarthritis.

Detailed description: Mesenchymal stem cells (MSCs) are nonhematopoietic progenitor cells isolated from adult tissues. These are characterized in vitro by their extensive proliferative ability in an uncommitted state while retaining the potential to differentiate along various lineages of mesenchymal origin, including chondrocyte, osteoblast, and adipocyte lineages, in response to appropriate stimuli.MSCs can be induced to undergo chondrogenic differentiation in vitro and in vivo. Centeno et al.in 2008 reported about the beneficial effects of autologous mesenchymal stem cells in osteoarthritis of knee. The regenerative effects of MSCs in osteoarthritis can be due to their ability to differentiate themselves into chondrocytes and structurally repair the articular cartilage. Recently, MSCs have been shown to possess many potent paracrine effects through secretion of various soluble factors which can influence the local tissue environment and exert protective effects with an end result of effectively stimulating regeneration in situ. Recently Amgad etal.in their study reported even more effective results with use of platelet rich plasma along with mesenchymal stem cells. Platelets play an instrumental role in the normal healing response via the localsecretion of growth factors and recruitment of reparative cells. Its use in orthopaedic began early in this decade as PRP was used with bone grafts to augment spinal fusion and fracture healing.

Wakitani et al. in 1994 described repair of defects in articular cartilage in rabbits.Murphy et al.studied the effects of autologous mesenchymal stem cells in caprine knee joints.Quarto et al.reported the ability of mesenchymal stem cells to repair a large musculoskeletal defect with successful healing of a large bone defect in three patients. Centeno et al. reported one case in which they showed that isolated and expanded autologous mesenchymal stem cells when percutaneously injected into a knee with symptomatic and radiographic osteoarthritis, resulted in significant cartilage growth, decreased pain and increased joint mobility. Mishra et al. reported that PRP could enhance the chondrogenic differentiation of MSCs, and that TGFbeta and fibroblast growth factor (FGF) signaling, which are factors present within PRP, were important for chondrogenic differentiation of MSCs.Hence present study is designed to study the efficacy of use of PRP enhanced mesenchymal stem cells in osteoarthritis knee.

AIMS AND OBJECTIVES

1. To evaluate the safety and efficacy of Platelet rich plasma enhanced autologous mesenchymal stem cells versus platelet rich plasma in knee osteoarthritis.
2. To correlate the clinical improvement with the radiological findings.

Eligibility criteria: Inclusion Criteria:

1. Grade 1 or Grade 2 Osteoarthritis knee as per Ahlbacks radiographic staging
2. Patients willing to give consent

Exclusion Criteria:

1. Osteoarthritis secondary to joint inflammatory diseases (eg- rheumatoid arthritis, ankylosing spondylitis etc)
2. Patients with other diseases, affecting the knee joint like crystal arthropathy, symptomatic chondrocalcinosis, acute synovitis, excessive joint effusion(\>100ml), cystic disease around the knee joint(eg-popliteal cyst)
3. Advanced stage of osteoarthritis
4. Bone marrow suppression
5. Co morbidities like pregnancy, cancer, immunosuppression,
6. Osteoarthritis secondary to trauma

Primary outcomes:
measure: Pain relief
timeFrame: Participants will be followed upto an average of 6months.
Secondary outcomes:
measure: Functional Outcome
timeFrame: Participants will be followed upto an average of 6months.
Other outcomes:
measure: Quantitative articular cartilage volume analysis
timeFrame: Participants will be followed upto an average of 6months.
Locations:
city: Chandigarh
country: India
facility: Department of Orthopaedics Postgraduate Institute of Medical Education & Research
Study officials:
affiliation: Post graduate institute of Medical Education & Research, Chandigarh, India
name: Aditya K Aggarwal, MS,DNB,DO
role: PRINCIPAL_INVESTIGATOR
References: