Back to results

Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis

Primary Purpose

RheumatoId Arthritis, Osteoarthritis, Knee, Osteoarthritis, Hip

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Stem Cell Transplantation

About this trial

This is an interventional treatment trial for RheumatoId Arthritis focused on measuring Stem cells, Rheumatoid arthritis

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

17-75 years old
The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before treatment.

Exclusion Criteria:

Subjects with addition major health condition/disease diagnoses
Subjects that are pregnant or breastfeeding

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cells

Arm Description

Autologous bone marrow-derived stem cell transplantation.

Outcomes

Primary Outcome Measures

Evaluation of Pain Reduction measured by VAS scaling

measured by VAS scaling

Secondary Outcome Measures

Evaluation of the Physical Activity measure by WOMAC scoring

Evaluation the resurfacing of articular cartilage by MRI

Full Information

NCT ID

NCT03067870

First Posted

February 25, 2017

Last Updated

March 15, 2020

Sponsor

Stem Cells Arabia

1. Study Identification

Unique Protocol Identification Number

NCT03067870

Brief Title

Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis

Official Title

Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stem Cells Arabia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis ultimately results in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that autologous bone marrow-derived mesenchymal and specific populations of stem cells has anti-inflammatory and regenerative effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of BM-SC transplantation in treatment of rheumatoid arthritis.

Detailed Description

Rheumatoid arthritis (RA) is a chronic autoimmune disorder that primarily affects joints. It typically results in swollen and painful joints. Pain and stiffness often worsen after rest. Most frequently, the wrist and hands are involved, with the same joints typically involved on both sides of the body. RA affects between 0.5-1% of adults in the developed world with between 5-50 per 100,000 people newly developing the disease each year. Onset is most frequent during middle age and women are affected 2.5 times as frequently as men. The goal of treatment is to reduce pain, decrease inflammation, and improve a person's overall functioning and quality of life. Herein, the investigators study the safety and efficacy of the immunomodulatory effects of bone marrow-derived stem cells administered intravenously and the regenerative and repair potential of bone marrow-derived stem cells transplanted into the joints of patients with RA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

RheumatoId Arthritis, Osteoarthritis, Knee, Osteoarthritis, Hip

Keywords

Stem cells, Rheumatoid arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stem Cells

Arm Type

Experimental

Arm Description

Autologous bone marrow-derived stem cell transplantation.

Intervention Type

Biological

Intervention Name(s)

Stem Cell Transplantation

Intervention Description

Intravenous administration of autologous bone marrow derived stem cells for immunomodulation. Transplantation of autologous bone marrow derived stem cells in joints.

Primary Outcome Measure Information:

Title

Evaluation of Pain Reduction measured by VAS scaling

Description

measured by VAS scaling

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Evaluation of the Physical Activity measure by WOMAC scoring

Time Frame

1 month

Title

Evaluation the resurfacing of articular cartilage by MRI

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 17-75 years old The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before treatment. Exclusion Criteria: Subjects with addition major health condition/disease diagnoses Subjects that are pregnant or breastfeeding

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs