Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01499056

Enrollment

Registered

2011-12-26

Start date

2010-06-30

Completion date

2011-03-31

Last updated

2011-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis

Keywords

osteoarthritis, hip joint, mesenchymal stem cell

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.

Interventions

BIOLOGICALstem cell injection

intra articular inection of mesenchymal stem cell

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
skin allergic reaction	1 week	Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.
Respiratory reaction	1 week	Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.
swelling of hip joint	2 months	Evaluatin the swelling of hip joint by physical examination after intra articular injection.
deterioration of joint function	2 months	Evaluation deterioration of joint function by physical examination after intra articular cell injection.

Secondary

Measure	Time frame	Description
Quantitative changes in pain intensity	2 months	Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)
physical function improvement	2 months	Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.
subchondral bone edema	2 months	Evaluation the subchondral bone edema by MRI
cartilage thickness	2 months	measuring the cartilage thickness after cell transplantation by MRI

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026