Will my bone marrow be harvested?
No. This is a treatment that uses allogeneic mesenchymal stem cells derived from donated umbilical cord blood.
OSANG STEM CELL CLINIC
Stem Cell Clinic
DOMESTIC APPROVED CELL THERAPIES
domestic permit
4 types of stem cell therapy
Each treatment has different cell sources, approved diseases, and application methods.
Osang Neurosurgery provides information on the scope and standards of official approval before the name.
Cell + Evidence = CARE
We're not just talking about possibilities. Check the approved standards first.
Accurate understanding of domestic stem cell therapy guided by OSANG01Subject to permitApproved Scope
02patient conditionPatient Criteria
03medical environmentClinical Setting
Care For
Patient · Condition · Safety
Stem cell is one word, but the origin, approval target, and administration environment of the cells are different.You can accurately understand the treatment by looking at the three criteria together.
Approval Standard
Even if it is an approved treatment
There are different criteria to check.
Ministry of Food and Drug Safety product approval is a standard for the targets and methods set for each product. You must determine whether it is right for the patient by looking at the diagnosis and approval conditions together.
STEP 01 · CELL SOURCE
What cell does it start in?
The manufacturing process and application method vary depending on whether the cells are your own or donated.
STEP 02 · APPROVED SCOPE
For which patients is it approved?
Even if the disease name is the same, detailed approval conditions such as severity, onset time, and testing criteria are checked together.
STEP 03 · ADMINISTRATION
How to apply it
The application environment for each treatment is different, such as surgical implantation, intravascular administration, and lesion site injection.
STEP 04 · CLINICAL SETTING
Where can it be implemented?
We check the standards of the medical environment, including specialized departments, facilities, and equipment required for each treatment.
Therapy Information
Approval scope of four treatments
We explain each step accurately.
Applicability is not determined based on the disease name alone. The officially approved targets, application methods, and limitations of each product are summarized in easy-to-understand language.
01 · CARTISTEM
Cartistem
This is an allogeneic cord blood-derived treatment for some patients whose knee cartilage is deeply damaged due to degenerative changes or repeated trauma.
Drugs approved by the Ministry of Food and Drug Safety
APPROVED SCOPE
What is it licensed for?
It is approved for the treatment of ICRS grade 4 cartilage defects in which the knee cartilage is deeply damaged down to the bone due to degenerative changes or repetitive trauma.
- cell derived
- Mesenchymal stem cells derived from donated cord blood
- Officially licensed
- knee cartilage defect
- Application method
- Surgical transplantation of cartilage defects
- Required medical environment
- Orthopedic surgery and rehabilitation linkage
CHECK 01
Criteria for confirming approval targets
- When the treatment area is the knee joint
- Cartilage defects caused by degenerative changes or repeated trauma
- When cartilage damage is confirmed as ICRS grade 4
- If you pass a surgical suitability evaluation including joint alignment and general condition
CHECK 02
This case is different from the scope of permission.
- Simple knee pain or early arthritis
- Diseases of joints other than the knee
- K&L grade 4, terminal arthritis based on X-ray
- Chronic inflammatory and autoimmune arthritis such as rheumatoid arthritis
- Severe leg deformation that makes it difficult to expect treatment results
- In case of hypersensitivity to related ingredients, anesthetics, gentamicin, etc.
TREATMENT FLOW
It usually goes like this.
Actual process and schedule may vary depending on patient condition and implementing agency.- 01
Orthopedic evaluation
The location and size of cartilage defects, degree of arthritis, and joint alignment are checked.
- 02
surgical approach
After anesthesia, the damaged area is checked through joint incision or arthroscopy.
- 03
Defect site preparation
Clean up damaged tissue and prepare the graft site according to the approved use.
- 04
Cell therapy transplantation
Cartistem and hyaluronic acid are mixed and filled in cartilage defects.
- 05
Rehabilitation/Follow-up
Weight bearing and rehabilitation period are determined depending on the extent of surgery and patient condition.
LIMITATIONS & SAFETY
Also check the limitations of treatment.
This treatment requires surgery and anesthesia and is not applicable to all arthritis patients. The Ministry of Food and Drug Safety's approval also states that the long-term effects and safety of the administered cells are not yet known.QUESTIONS & ANSWERS
Frequently Asked Questions
Is it a treatment where you just get an injection and go home?
No. The damaged cartilage area is surgically prepared, a treatment agent is implanted, and a rehabilitation process is performed.
Does ICRS grade 4 mean terminal arthritis?
ICRS and K&L are different evaluation standards. Cartilage defects must be ICRS grade 4, but K&L grade 4, which is terminal arthritis on X-ray, is a contraindication to administration.
02 · HEARTICELLGRAM-AMI
Hearticellgram-AMI
It is an autologous bone marrow-derived treatment for selected patients with acute myocardial infarction who have undergone coronary angioplasty within a limited period of time.
Drugs approved by the Ministry of Food and Drug Safety
APPROVED SCOPE
What is it licensed for?
It is approved for the purpose of improving heart function in patients who undergo coronary angioplasty within a specified time after acute myocardial infarction and whose left ventricular ejection fraction is less than 40%.
- cell derived
- Mesenchymal stem cells derived from the patient's own bone marrow
- Officially licensed
- Acute myocardial infarction that meets the criteria
- Application method
- Intracoronary administration
- Required medical environment
- Cardiovascular interventional environment
CHECK 01
Criteria for confirming approval targets
- When diagnosed with acute myocardial infarction
- When blood flow is restored through coronary angioplasty within 72 hours from the start of chest pain
- When the left ventricular ejection fraction is less than 40%
- When autologous bone marrow collection and cardiac catheterization are possible
CHECK 02
This case is different from the scope of permission.
- Myocardial infarction that occurred a long time ago
- Common chronic heart failure or simple chest pain
- For the treatment of neurological diseases such as cerebral infarction and Parkinson's disease
- If you cannot undergo cardiac catheterization or coronary angiography
- If coronary artery blood flow disorder remains before administration
- Use of cells from someone else rather than the patient's own bone marrow cells
TREATMENT FLOW
It usually goes like this.
Actual process and schedule may vary depending on patient condition and implementing agency.- 01
acute care
Blocked blood vessels are first reopened with coronary angioplasty.
- 02
Conformity assessment
Check the approval conditions, including the time of onset, procedure time, and left ventricular ejection fraction.
- 03
Autologous bone marrow collection and production
The treatment is manufactured by collecting cells from the patient's own bone marrow.
- 04
Coronary artery administration
The treatment is divided and administered into the coronary artery using a balloon catheter.
- 05
Cardiac function follow-up
After administration, coronary blood flow, heart function, and adverse reactions are checked.
LIMITATIONS & SAFETY
Also check the limitations of treatment.
The approved efficacy is improvement of left ventricular ejection fraction. It is not intended to cure myocardial infarction, prevent recurrence, or reduce mortality. The expected benefits and risks of the procedure must be weighed together by your cardiologist.QUESTIONS & ANSWERS
Frequently Asked Questions
Is this a myocardial infarction prevention shot?
No. This is a treatment applied to some patients who have already suffered an acute myocardial infarction and have had their blood vessels reopened within a set time.
Is it an appropriate treatment like intravenous fluids?
No. It is administered into the coronary artery in an environment where cardiovascular intervention is possible.
Can it also be used for cerebral infarction?
No. Hearticellgram-AMI is eligible for approval for patients with acute myocardial infarction who meet all conditions.
03 · CUPISTEM
Cupistemju
It is an autologous cell therapy that injects the patient's own fat-derived cells into the fistula caused by Crohn's disease.
Drugs approved by the Ministry of Food and Drug Safety
APPROVED SCOPE
What is it licensed for?
It is approved for the treatment of fistulas caused by Crohn's disease. It is not a drug that treats all symptoms of Crohn's disease, but rather targets the fistula.
- cell derived
- Mesenchymal stem cells derived from the patient's own fat
- Officially licensed
- Fistula caused by Crohn's disease
- Application method
- Topical administration at the fistula site
- Required medical environment
- Autologous cell manufacturing and fistula surgery linkage
CHECK 01
Criteria for confirming approval targets
- When a fistula occurs due to Crohn's disease
- When the location, length, and diameter of the fistula can be evaluated
- When autologous fat tissue can be collected and cells can be manufactured
- When infection and Crohn's disease activity are managed to a level where surgery is possible
CHECK 02
This case is different from the scope of permission.
- General anal disease or fistula not related to Crohn's disease
- Severely active Crohn's disease
- If you have a bacterial infection
- When it is not possible to collect your own fat
- In case of hypersensitivity to related ingredients, anesthetics, fibrin glue, etc.
- For treatment of simple abdominal pain, diarrhea or enteritis
TREATMENT FLOW
It usually goes like this.
Actual process and schedule may vary depending on patient condition and implementing agency.- 01
Fistula evaluation
The location and type of the fistula, the activity of Crohn's disease, and infection are checked.
- 02
Autologous fat harvesting
After anesthesia, the patient's own fat tissue is collected.
- 03
cell manufacturing
Mesenchymal stem cells are separated from the collected fat and cultured and manufactured.
- 04
Fistula site preparation
The abscess and granulation tissue are removed, and the inner opening of the fistula is cleaned.
- 05
topical administration
Cell therapy is administered around the fistula and under the mucous membrane.
- 06
follow-up observation
Check the fistula closure status and the presence of pain, bleeding, or infection.
LIMITATIONS & SAFETY
Also check the limitations of treatment.
This treatment requires a combination of fat harvesting and fistula surgery. Depending on the patient's cell condition, manufacturing the treatment may be difficult or may not be made in sufficient quantity, and its long-term effectiveness and safety are not yet known.QUESTIONS & ANSWERS
Frequently Asked Questions
Is the fat injected as is?
No. It is a prescription drug made by isolating and culturing mesenchymal stem cells from harvested fat.
Is this treatment a cure for Crohn's disease?
No. Applicable for approval are fistulas caused by Crohn's disease and existing Crohn's disease treatment and management are still required.
Can other people use the same product?
No. Since it is an autologous cell therapy product made from the patient's own cells, it can only be used by the patient.
04 · NEURONATA-R
Neuronata-Alju
It is an autologous bone marrow-derived cell therapy for some patients with Lou Gehrig's disease that meets all current approval criteria.
Drugs approved by the Ministry of Food and Drug Safety
APPROVED SCOPE
What is it licensed for?
It is approved to slow the progression of some patients with amyotrophic lateral sclerosis (ALS) who are taking Riluzole together and whose rate of functional decline has been confirmed to be within the approved standard in repeated tests.
- cell derived
- Mesenchymal stem cells derived from the patient's own bone marrow
- Officially licensed
- ALS meets approval criteria
- Application method
- Intrathecal administration
- Required medical environment
- ALS specialized evaluation/hospitalization observation
CHECK 01
Criteria for confirming approval targets
- If you are diagnosed with amyotrophic lateral sclerosis, or ALS
- If you are taking riluzole together
- When the ALSFRS-R functional decline rate is confirmed to be less than 1.02 points per month
- When autologous bone marrow collection and intrathecal administration are possible
CHECK 02
This case is different from the scope of permission.
- When applied collectively to all ALS patients
- When the rate of functional decline is faster than the current approval standard
- Other neurological diseases such as Parkinson's disease, cerebral infarction, dementia, etc.
- Random use without concomitant use of riluzole
- When autologous bone marrow cannot be collected
- In case of bleeding tendency or hypersensitivity to related ingredients or antibiotics
TREATMENT FLOW
It usually goes like this.
Actual process and schedule may vary depending on patient condition and implementing agency.- 01
ALS Professional Assessment
The ALSFRS-R is measured repeatedly to calculate the actual rate of functional decline.
- 02
Check concomitant medications and overall condition
Check whether you are taking Riluzole, your overall condition, and whether you meet the conditions for official approval.
- 03
Bone marrow and cerebrospinal fluid collection
We manufacture cell therapy products by collecting raw materials from patients themselves.
- 04
Intrathecal administration
A dose appropriate for body weight is administered through spinal tap.
- 05
two treatments
Administer twice in total at 26-day intervals according to the approved dosage.
- 06
Inpatient observation
Monitor for acute adverse reactions at least one day after administration.
LIMITATIONS & SAFETY
Also check the limitations of treatment.
It is not a treatment to revive damaged motor nerves or cure ALS. The purpose of approval is to slow the rate of disease progression in some patients who meet the criteria, and long-term effectiveness and safety are not yet known.QUESTIONS & ANSWERS
Frequently Asked Questions
Is treatment possible for anyone diagnosed with ALS?
No. Repeated evaluations are required to calculate actual progress and meet all current official licensing criteria.
Can Lou Gehrig's disease be completely cured?
No. The approved goal is to slow the rate of functional decline in some patients who meet the conditions.
Can it be used for Parkinson's disease or cerebral infarction?
No. Neuronata-R is not an approved treatment for Parkinson's disease or cerebral infarction.
Evidence Standard
Before the name of the treatment,
Check official licensing information.
For the latest efficacy/effects, usage/dosage, contraindications, and adverse reactions, you must first check the latest approvals from the Ministry of Food and Drug Safety.
View the approval conditions for each product, including disease name, severity, and application method.
We provide guidance based on MFDS Drug Safety Korea and the manufacturer's official information.
At A Glance
Compare your treatments at a glance.
Even if the stem cell therapy is the same, it differs in whether it is applied using own cells or donor cells, and in what area and method it is applied.
| cure | cell derived | Officially licensed | Application method |
|---|---|---|---|
| Cartistem | Mesenchymal stem cells derived from donated cord blood | knee cartilage defect | Surgical transplantation of cartilage defects |
| Hearticellgram-AMI | Mesenchymal stem cells derived from the patient's own bone marrow | Acute myocardial infarction that meets the criteria | Intracoronary administration |
| Cupistemju | Mesenchymal stem cells derived from the patient's own fat | Fistula caused by Crohn's disease | Topical administration at the fistula site |
| Neuronata-Alju | Mesenchymal stem cells derived from the patient's own bone marrow | ALS meets approval criteria | Intrathecal administration |