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Mesenchymal Stem cells derived from human umbilical cord and its products to treat osteoarthritis

The effect of mesenchymal Stem cells derived from human umbilical cord and its products to treat osteoarthritis: production and clinical trial of safety, feasibility, and effectiveness

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241008063300N1
Enrollment
96
Registered
2024-10-19
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Osteoarthritis. Osteoarthritis of knee

Interventions

Intervention 1: Control group: The group receiving hyaluronic acid (Viscor ampoule, Nitka) via intra-articular injection of hyaluronic acid in the knee at the beginning and 6 months after the start of

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Having mild to moderate osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria (pain in the knee and at least three of the following: age> 50 years, stiffness< 30 minutes, crepitus, bone tenderness, bone enlargement, and no presence of palpable heat) Having Kellgren-Lawrence radiological criteria grade 1, 2 and 3 Obtaining a score of at least 5 from the VAS pain visual analog scale Lack of response to previous conservative treatments

Exclusion criteria

Exclusion criteria: Patients with rheumatological problems such as rheumatoid arthritis, history of knee joint surgery, history of lower limb bone fracture with knee joint surface involvement Previous diagnosis of polyarthritis Severe extra-articular mechanical deformity (>15 degrees of varus/15 degrees of valgus) Severe osteoarthritis of the knee (radiology score 4),5. People with a history of kidney and liver disease according to the patient's statements People taking anticoagulant drugs People with neuropathy and sensory disorders and skin disease in the knee area Chronic treatment with suppressive drugs, treatment with corticosteroids and treatment with PRP in the last 3 months, non-steroidal anti-inflammatory drugs in the last 15 days OA Bilateral knee osteoarthritis that requires treatment in both knees10. Poorly controlled diabetes, blood dyscrasia, and allergy to HA or bird proteins Existence of inflammatory symptoms and effusion in the joint

Design outcomes

Primary

MeasureTime frame
Changes in average pain intensity score. Timepoint: 1, 3, 6, and 12 months after the start of the intervention. Method of measurement: Visual Analogue Scale (VAS).;Changes in the mean functional disability score. Timepoint: 1, 3, 6, and 12 months after the start of the intervention. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) and Lequesne Indices.

Secondary

MeasureTime frame
The amount and severity of adverse events. Timepoint: 1, 3, 6, and 12 months after the start of the intervention. Method of measurement: The average quality of life score obtained from the SF-36 quality of life questionnaire.;The level of satisfaction with the received intervention. Timepoint: 1, 3, 6, and 12 months after the start of the intervention. Method of measurement: The average quality of life score obtained from the SF-36 quality of life questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbolfazl Barzegari

Tabriz University of Medical Sciences

barzegari.abolfazl@gmail.com+98 41 3177 4523

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026