A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis

Cura Biotech

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Osteoarthritis

Rheumatoid Arthritis

Treatments

Drug: Cura-100

Study type

Interventional

Funder types

Industry

Identifiers

NCT00455208

CURA-07-10

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.

Full description

This is the Phase I/II trial, which monitors both safety and efficacy of Cura-100 in subjects with rheumatoid arthritis and osteoarthritis at one clinical study center. The open-label clinical study will be used in the study. The study is expected to last for one and a half year after it has been officially started, which include recruitment, study treatment and follow-ups. The healthy volunteers are also included to study the safety of the intervention.

Enrollment

20 estimated patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage
Able and willing to comply with study visits and procedures specified in this protocol for at least six months period
Able to understand and willing to sign and date the written informed consent form prior to admission of the study
Able and willing to provide adequate information for locator purposes
Able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation

Exclusion criteria

Pregnant women
Over-weighted
Hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation
Patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded
Unable to spend 3 hours for treatment at the study center