Clinical trial NCT01499056: Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
Official title: Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hip Osteoarthritis
Keywords: osteoarthritis
hip joint
mesenchymal stem cell
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2011-12-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis

Detailed description: This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis diagnosed by MRI
* End stage osteoarthritis candidate for total hip replacement

Exclusion Criteria:

* Pregnancy or lactating
* Positive tests for HIV, HCV, HBV
* Active neurologic disorder
* End organ damage
* Uncontrolled endocrine disorder

Primary outcomes:
measure: swelling of hip joint
timeFrame: 2 months
measure: deterioration of joint function
timeFrame: 2 months
measure: skin allergic reaction
timeFrame: 1 week
measure: Respiratory reaction
timeFrame: 1 week
Secondary outcomes:
measure: Quantitative changes in pain intensity
timeFrame: 2 months
measure: physical function improvement
timeFrame: 2 months
measure: subchondral bone edema
timeFrame: 2 months
measure: cartilage thickness
timeFrame: 2 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Royan Cell therapy Center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: scientist
name: Mohsen Emadeddin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.