December 26, 2017

Bone & Joints

Osteoarthritis

The osteoarthritis disorders are known as arthritis that usually occurs after middle age. It is one of the diseases that causes physical and psychological damage to patients. Given the heavy financial burden that health care imposing on the patients as same as the country. Various therapeutic approaches have been proposed to treat this disorder including drug therapy, rehabilitation and surgery.

Treatment with anti-inflammatory drugs and analgesics has several complications for the patients, which in the best case is limited to gastrointestinal complication. But taking these relief medications in addition to gastrointestinal complication can cause problems in blood coagulation, kidneys or even cardiovascular disease.

Therefore, one of the best method to treat the arthritis is using cartilage regeneration which can be noted for joint replacement. However, joint replacement surgery, in addition to having an artificial joint in the body, costs a lot that may be in the best conditions Joint prosthesis life time is just 10 years. In addition, the prosthesis need to replace several time during the patient’s life that can be out of the patient’s physical and financial capacity. Therefore, a specific need to find new and cost effective solutions as an alternative to previous treatments has been required. Nowadays, an effective and new therapeutic approaches, such as cell therapy, has come to the fore. In this therapeutic approach, bone marrow derived cells from the patients are used to treat osteoarthritis.

 

Treatment stages

In this stage, the patient is examined by a specialist and if osteoarthritis symptoms are confirmed, further examinations will be done on the patients. The cell therapy can be used for the young patients or the patients with limited joint destruction which does not require a joint replacement.

For cell therapy, a cell sample is taken from the patient’s pelvic bone and Isolated in the stem cell laboratory and eventually injected into the patient’s joint by an orthopedic specialist. The injection of these cells will not have any complications and most of these cells are most effective in the first injection and does not need reinjected.

Several studies on intracellular stem cell transplantation in osteoarthritis patients have shown great efficacy and improved quality of patient’s life. There is no side effect report till now and this treatment procedure has been observed safe and more cost effective.

 

Cell therapy using Mesenchymal stem cell (MSC)

Mesenchymal stem cell (MSC) are powerful cells with potential for ossification, building of cartilage, fatty tissues, tendon, muscle, and types of connective tissues. These cells exist in various tissues such as liver, spleen, muscle, brain, thymus, and bone marrow. In most cases, they are derived from bone marrow. MSCs are required in keeping balance of immunity system and the secreted factors from these cells cause tissue recovery and reduce inflammation. In the tissue damage case, MSCs migrate to damaged area and settle there to exert their unique effects. Given that they are found in many tissues, unlike the classic method of tissue engineering, there is no need to use arthroscopy to provide the cells. MSCs have higher potential and capacity for differentiation and almost easily isolated to culture in vitro. These cells may reproduce each other without losing their differentiation capacity. Their unique characteristics provide very appropriate choice for therapy purposes and researches. Use of these cells not only facilitate recovery of cartilage, but also reconstruct other tissues such as subchondral bone, ligament, knee meniscus, and pelvic labrum. Similarity the other advantage is the possibility for treatment of great cartilaginous defects.

 

Study 1

In this study, the safety and efficacy of intracranial transplantation of bone marrow stem cells was studied in patients with knee osteoarthritis.

Patient selection:

In this study, esteoartirits patients to cartilage lesion of the knee who have been admitted to the Orthopedic Clinic of Royan Institute. Based on inclusion and exclusion criteria that will be discussed in following. 46 patients were selected for inclusion to study and informed consent was obtained from them. Patients were randomly divided into two groups, 23 patients were in clinical trial groups and 23 patients were in placebo groups.

Inclusion criteria:

1-Ranging in age of 18-65 years

2- In both of gender

3- Osteoarthritic with pain according to Kellgren & Lawrence (Grade 2 and 3 respectively)

4-Malalingment of knee joint is less than 30 degrees. (Recognition by three joint view graph)

5-The visual analogue scale of patient is more or equal to 4.

6- The patient is given a written consent.

Exclusion criteria:

1-Coagulopathy diseases or are taking anticoagulation

2-Immunodeficiency diseases

3-With a history of any cancer

4- Acute or chronic uncontrolled diseases such as uncontrolled diabetes mellitus, uncontrolled high blood pressure, uncontrolled endocrine system diseases, etc.

5- Underlying disease need to have a combination of corticosteroids during the study.

6-Patients with viral diseases such as hepatitis or AIDS.

7-Evidence of infection or severe inflammation to be seen in the knee joint.

8-BMI is equal or greater than 35.

9- The patient does not consent to participate in the study.

 

Method of bone marrow aspiration:

After patient selection and confirmation of the possibility of local anesthesia for prominent of Iliac Crest bilateral under sterile conditions, the bone marrow specimens received for localization of mesenchymal cells.

Cell separation and cell culture: The mesenchymal cells are derived from bone marrow specimens and cultured.

Cell infusion: The cells are injected intra-articular which is containing 20 million cells for each knee.

Outcomes of Treatment

The primary outcome:

The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain

The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site

Other disorders associated with the injection process, possibly related to cell therapy: Tumorigenesis at the injection site, dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection

 

The secondary outcome:

  • The morning stiffness and symptoms of disorder on the WOMAC questionnaire (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The blood, liver, kidney and nervous disorders (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The pain severity based on VAS procedure (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The mileage by patient (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The mesurment level of ESR (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • Doing Knee MRI for evaluation of cartilage repair (scheduled: Before transplantation, 6, 12 months after transplantation)
  • Life quality of patient evaluation based on SF36 questionnaire (scheduled: Before transplantation, 12 months after transplantation)

Result of study:

The study included a 46-member group of patients with knee osteoarthritis was injected under the criteria aforementioned. The clinical criteria of patients including WOMAC and other subgroups such as pain, physical activity, morning stiffness and average distance walking improved rather than placebo groups. These values were improved at 3-6 months of post-injection in the cell therapy group.

Images

Above images show MRI of 56-year-old woman with knee osteoarthritis.

  1. The image before the injection indicates edema areas in the sub cartilage
  2. The image 6 months after injection shows an increase in the signal at the site of the articular cartilage.

Study 2

In this study, the safety and efficacy of intracranial transplantation of bone marrow stem cells was studied in patients with knee osteoarthritis.

Patient selection:

In this study, esteoartirits patients to cartilage lesion of the knee who have been admitted to the Orthopedic Clinic of Royan Institute. Based on inclusion and exclusion criteria that will be discussed in following. 6 patients were selected for inclusion to study and informed consent was obtained from them.

 

Inclusion criteria:

1-Ranging in age of 18-65 years

2- In both of gender

3- Osteoarthritic with pain according to Kellgren & Lawrence (Grade 2 and 3 respectively)

4-Malalingment of knee joint is less than 30 degrees. (Recognition by three joint view graph)

5-The visual analogue scale of patient is more or equal to 4.

6- The patient is given a written consent.

 

Exclusion criteria:

1-Coagulopathy diseases or are taking anticoagulation

2-Immunodeficiency diseases

3-With a history of any cancer

4- Acute or chronic uncontrolled diseases such as uncontrolled diabetes mellitus, uncontrolled high blood pressure, uncontrolled endocrine system diseases, etc.

5- Underlying disease need to have a combination of corticosteroids during the study.

6-Patients with viral diseases such as hepatitis or AIDS.

7-Evidence of infection or severe inflammation to be seen in the knee joint.

8-BMI is equal or greater than 35.

9- The patient does not consent to participate in the study.

 

Method of bone marrow aspiration:

To prepare a bone marrow sample for bone marrow cell suspension, patients under the bone marrow spit of the pelvis with local anesthesia.

Cell separation and cell culture: The mesenchymal cells are derived from bone marrow specimens and cultured.

Cell infusion: The cells are injected intra-articular which is containing 20 million cells for each knee.

Outcomes of Treatment

The primary outcome:

Incidence of adverse events:

 

The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain

The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site

Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site

Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection

 

The secondary outcome:

  • The morning stiffness and symptoms of disorder on the WOMAC questionnaire (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The blood, liver, kidney and nervous disorders (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The pain severity based on VAS procedure (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The mileage by patient (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The mesurment level of ESR (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • Doing Knee MRI for evaluation of cartilage repair (scheduled: Before transplantation, 6, 12 months after transplantation)
  • Life quality of patient evaluation based on SF36 questionnaire (scheduled: Before transplantation, 12 months after transplantation)

 

Result of study:

Visual analogue scale average which represents pain in the patient’s view. In these patients, the average were decreased from 9.8 to 6.3. WOMAC form received from patients to evaluate pain amount and physical activity. During 6 months, WOMAC number of patients were decreased from 2.95 to 1.97 which represents patient’ performance improvement in this 6 months.

 

Study 3

In this study, the safety and efficacy of intracranial transplantation of bone marrow stem cells was studied in patients with knee osteoarthritis.

Patient selection:

In this study, esteoartirits patients to cartilage lesion of the knee who have been admitted to the Orthopedic Clinic of Royan Institute. Based on inclusion and exclusion criteria that will be discussed in following. 38 patients were selected for inclusion to study and informed consent was obtained from them. Patients were randomly divided into two groups, 19 patients were in clinical trial groups and 19 patients were in placebo groups.

 

Inclusion criteria:

1-Ranging in age of 18-65 years

2- In both of gender

3- Osteoarthritic with pain according to Kellgren & Lawrence (Grade 2 and 3 respectively)

4-Malalingment of knee joint is less than 30 degrees. (Recognition by three joint view graph)

5-The visual analogue scale of patient is more or equal to 4.

6- The patient is given a written consent.

 

Exclusion criteria:

1-Coagulopathy diseases or are taking anticoagulation

2-Immunodeficiency diseases

3-With a history of any cancer

4- Acute or chronic uncontrolled diseases such as uncontrolled diabetes mellitus, uncontrolled high blood pressure, uncontrolled endocrine system diseases, etc.

5- Underlying disease need to have a combination of corticosteroids during the study.

6-Patients with viral diseases such as hepatitis or AIDS.

7-Evidence of infection or severe inflammation to be seen in the knee joint.

8-BMI is equal or greater than 35.

9- The patient does not consent to participate in the study.

Method of bone marrow aspiration:

To prepare a bone marrow sample for bone marrow cell suspension, patients under the bone marrow spit of the pelvis with local anesthesia.

Cell separation and cell culture: The mesenchymal cells are derived from bone marrow specimens and cultured.

Cell infusion: The cells are injected intra-articular which is containing 20 million cells for each knee.

Outcomes of Treatment

The primary outcome:

Incidence of adverse events:

The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain

The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site

Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site

Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection

 

The secondary outcome:

  • The morning stiffness and symptoms of disorder on the WOMAC questionnaire (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The blood, liver, kidney and nervous disorders (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The pain severity based on VAS procedure (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The mileage by patient (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The mesurment level of ESR (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • Doing Knee MRI for evaluation of cartilage repair (scheduled: Before transplantation, 6, 12 months after transplantation)
  • Life quality of patient evaluation based on SF36 questionnaire (scheduled: Before transplantation, 12 months after transplantation)

 

Result of study:

In this study, Patients were randomly divided into two groups, 19 patients were in clinical trial groups and 19 patients were in placebo groups. The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain. The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site. Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site. Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection. There is no side effects till now.

 

Secondary Results:

Comparing the results of cell therapy which represents the cell therapy group’s result were better than the placebo group.

Study 4

In this study, the safety and efficacy of intracranial transplantation of bone marrow stem cells was studied in patients with knee osteoarthritis.

Patient selection:

In this study, esteoartirits patients to cartilage lesion of the knee who have been admitted to the Orthopedic Clinic of Royan Institute. Based on inclusion and exclusion criteria that will be discussed in following. 6 patients were selected for inclusion to study and informed consent was obtained from them.

Inclusion criteria:

1-Ranging in age of 18-65 years

2- In both of gender

3- Osteoarthritic with pain according to Kellgren & Lawrence (Grade 2 and 3 respectively)

4-Malalingment of knee joint is less than 30 degrees. (Recognition by three joint view graph)

5-The visual analogue scale of patient is more or equal to 4.

6- The patient is given a written consent.

 

Exclusion criteria:

1-Coagulopathy diseases or are taking anticoagulation

2-Immunodeficiency diseases

3-With a history of any cancer

4- Acute or chronic uncontrolled diseases such as uncontrolled diabetes mellitus, uncontrolled high blood pressure, uncontrolled endocrine system diseases, etc.

5- Underlying disease need to have a combination of corticosteroids during the study.

6-Patients with viral diseases such as hepatitis or AIDS.

7-Evidence of infection or severe inflammation to be seen in the knee joint.

8-BMI is equal or greater than 35.

9- The patient does not consent to participate in the study.

Method of bone marrow aspiration:

To prepare a bone marrow sample for bone marrow cell suspension, patients under the bone marrow spit of the pelvis with local anesthesia.

Cell separation and cell culture: The mesenchymal cells are derived from bone marrow specimens and cultured.

Cell infusion: The cells are injected intra-articular which is containing 20 million cells for each knee.

Outcomes of Treatment

The primary outcome:

Incidence of adverse events:

The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain

The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site

Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site

Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection

 

The secondary outcome:

  • The morning stiffness and symptoms of disorder on the WOMAC questionnaire (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The blood, liver, kidney and nervous disorders (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The pain severity based on VAS procedure (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The mileage by patient (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The mesurment level of ESR (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • Doing Knee MRI for evaluation of cartilage repair (scheduled: Before transplantation, 6, 12 months after transplantation)
  • Life quality of patient evaluation based on SF36 questionnaire (scheduled: Before transplantation, 12 months after transplantation)

Result of study:

In this study, 6 Patients which have esteoartirits of knee cartilage lesion were under studied. After 1 year follow up of patients and evaluated side effects including: The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain. The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site. Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site. Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection. There is no side effects till now.

Walking distance average of patients in first part of study was 88.3±93.2 which were significantly increased during 6 months. This amount was 400± 427.2m and reached to 1032.2 ± 1222.0m. Total WOMAC reached from 45.5 to 72.2 in month of 6 and 47.2 in month of 12. The stiffness subscore of WOMAC reached from 31.2 to 10.6 and WOMAC physical function subscore were decreased in the month of 6 and 12.

Comparison of various indexes: before and after of MSC injection.

 

Study 5

In this study, the safety and efficacy of intracranial transplantation of bone marrow stem cells was studied in patients with hype osteoarthritis.

Patient selection:

In this study, esteoartirits patients to cartilage lesion of the hype who have been admitted to the Orthopedic Clinic of Royan Institute. Based on inclusion and exclusion criteria that will be discussed in following. 6 patients were selected for inclusion to study and informed consent was obtained from them.

Inclusion criteria:

1-Ranging in age of 18-65 years

2- In both of gender

3- Osteoarthritic with pain according to Kellgren & Lawrence (Grade 2 and 3 respectively)

4-The visual analogue scale of patient is more or equal to 4.

5- The patient is given a written consent.

 

Exclusion criteria:

1-Coagulopathy diseases or are taking anticoagulation

2-Immunodeficiency diseases

3-With a history of any cancer

4- Acute or chronic uncontrolled diseases such as uncontrolled diabetes mellitus, uncontrolled high blood pressure, uncontrolled endocrine system diseases, etc.

5- Underlying disease need to have a combination of corticosteroids during the study.

6-Patients with viral diseases such as hepatitis or AIDS.

7-Evidence of infection or severe inflammation to be seen in the knee joint.

8-BMI is equal or greater than 35.

9- The patient does not consent to participate in the study.

 

Method of bone marrow aspiration:

To prepare a bone marrow sample for bone marrow cell suspension, patients under the bone marrow spit of the pelvis with local anesthesia.

Cell separation and cell culture: The mesenchymal cells are derived from bone marrow specimens and cultured.

Cell infusion: The cells are injected intra-articular which is containing 20 million cells for each knee.

Outcomes of Treatment

The primary outcome:

Incidence of adverse events:

The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain

The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site

Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site

Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection.

 

The secondary outcome:

  • The morning stiffness and symptoms of disorder on the WOMAC questionnaire (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The blood, liver, kidney and nervous disorders (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The pain severity based on VAS procedure (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The mileage by patient (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The mesurment level of ESR (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • Doing Knee MRI for evaluation of cartilage repair (scheduled: Before transplantation, 6, 12 months after transplantation)
  • Life quality of patient evaluation based on SF36 questionnaire (scheduled: Before transplantation, 12 months after transplantation)

 

Result of study:

In this study, 6 Patients which have esteoartirits of hips cartilage lesion were under studied. After 1 year follow up of patients and evaluated side effects including: The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain. The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site. Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site. Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection. There is no side effects till now.

Secondary Outcome:

Walking distance average of patients in first part of study was 370m which were significantly increased to 1170m during 6 months. Total WOMAC reached from 45.2± 10.0 to 26.3± 11.6 m in month of 12. The Pain sub score of WOMAC reached from 31.2 to 24.2± 25. Woman stiffness sub score were decreased in month of 6 and 12. WOMAC physical phanction sub score reached from 18.6±28.4 in month of 12 to 20.6 ±30.8 in month of 30 while the basic amount was 52.7±11.2. The harriss hip score after treatment reached to 16.8±79.8 while the basic amount was 3.2±57.0.

The percent of different injection cells in hip arthritis

Comparison of various indexes: before and after of MSC injection.

Study 6

In this study, the safety and efficacy of intracranial transplantation of bone marrow stem cells was studied in patients with ankle osteoarthritis.

Patient selection:

In this study, esteoartirits patients to cartilage lesion of the ankle arthritis who have been admitted to the Orthopedic Clinic of Royan Institute. Based on inclusion and exclusion criteria that will be discussed in following. 6 patients were selected for inclusion to study and informed consent was obtained from them.

Inclusion criteria:

1-Ranging in age of 18-65 years

2- In both of gender

3- Osteoarthritic with pain according to Kellgren & Lawrence (Grade 2 and 3 respectively)

4-The visual analogue scale of patient is more or equal to 4.

5- The patient is given a written consent.

 

Exclusion criteria:

1-Coagulopathy diseases or are taking anticoagulation

2-Immunodeficiency diseases

3-With a history of any cancer

4- Acute or chronic uncontrolled diseases such as uncontrolled diabetes mellitus, uncontrolled high blood pressure, uncontrolled endocrine system diseases, etc.

5- Underlying disease need to have a combination of corticosteroids during the study.

6-Patients with viral diseases such as hepatitis or AIDS.

7-Evidence of infection or severe inflammation to be seen in the knee joint.

8-BMI is equal or greater than 35.

9- The patient does not consent to participate in the study.

 

Method of bone marrow aspiration:

To prepare a bone marrow sample for bone marrow cell suspension, patients under the bone marrow spit of the pelvis with local anesthesia.

Cell separation and cell culture: The mesenchymal cells are derived from bone marrow specimens and cultured.

Cell infusion: The cells are injected intra-articular which is containing 20 million cells for each knee.

Outcomes of Treatment

The primary outcome:

Incidence of adverse events:

The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain

The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site

Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site

Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection.

 

The secondary outcome:

  • The morning stiffness and symptoms of disorder on the WOMAC questionnaire (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The blood, liver, kidney and nervous disorders (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The pain severity based on VAS procedure (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • The mileage by patient (scheduled: Before transplantation, 1, 3, 6, 12 months after transplantation)
  • The mesurment level of ESR (scheduled: Before transplantation, 3, 6, 12 months after transplantation)
  • Doing Knee MRI for evaluation of cartilage repair (scheduled: Before transplantation, 6, 12 months after transplantation)
  • Life quality of patient evaluation based on SF36 questionnaire (scheduled: Before transplantation, 12 months after transplantation)

 

Result of study:

In this study, 6 Patients which have esteoartirits of ankle cartilage lesion were under studied. After 1 year follow up of patients and evaluated side effects including: The short-term problems associated with the injection process: Such as infection at the injection site, redness, severe pain. The long-term problems associated with the injection process: Prolonged infection, prolonged redness, severe pain at the injection site. Other disorder not associated with the injection process and possibly related to cell therapy: Tumorigenesis at the injection site. Other disorders of the organs after injection: dyslipidemia, liver dysfunction, thyroid dysfunction, anemia, and any new abnormality in laboratory tests patients after injection. There is no side effects till now.

 

Secondary Outcome:

Walking distance average of patients in first part of study was 1010m which were significantly increased to 2333m in month of 12. The stiffness sub score of WOMAC in the month of 6 reached to 8.3±14.0 and in the month of 12 reached to 14.8±18.7, in the month of 30 reached to 4.1±3.6 which represents the significantly decreased. The WOMAC sub score of pain from 16.7± 40.0 as a basic amount reached to 16.9± 29.0 in month of 6 and 14.8± 25.0 in the month of 12 and in the last reached to 19.7± 24.3 in the month of 30.

. Total WOMAC reached from 45.2± 10.0 to 26.3± 11.6 m in month of 12. The Pain sub score of WOMAC reached from 31.2 to 24.2± 25. Woman stiffness sub score were decreased in month of 6 and 12. WOMAC physical phanction sub score reached from 18.6±28.4 in month of 12 to 20.6 ±30.8 in month of 30 while the basic amount was 52.7±11.2. The harriss hip score after treatment reached to 16.8±79.8 while the basic amount was 3.2±57.0. The Womac physical phanction subscore reached to 35.5±20.0 in the month of 6 to 19.7±24.3 in the month of 12 after injection. The FAQ reached from 10.4±55.6 in the month of 6 to 4.9±58.3 in the month of 12 after injection