Osteonecrosis of Femoral HeadPhase 1/2NCT03180463

The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)

A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and core decompression in people with Osteonecrosis of Femoral Head, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients. Read more about this study

Who is it for?: Any age
Conditions the study is for: Osteonecrosis of Femoral Head
What is being tested?: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) and core decompression
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteChina
Study dates: 31 Dec 2026to 31 Dec 2027
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Ficat classification is I, IIa, or IIb period
no obvious improvement or ingravescence by conservative treatment
patients or their statutory receive human umbilical cord mesenchymal stem cell of their own will, and signed informed consent form

Who cannot join

Ficat classification is third or fourth period
acute, chronic infection patients
combined with heart, lung, kidney disease, and cannot tolerate operation
ankylosing spondylitis patient
acetabular dysplasia patient
with tumor

Show all 10Show fewer

clinical data deficient
HIV positive
pregnancy or breast feeding women
under other therapy that possibly influence MSC security or efficacy

Trial locations and contacts

1 site in 1 country.

China1 site

Inner Mongolia International Mongolian Hospital
Hohhot, Inner Mongolia, 010065

Other trials in China

About this study

Official title: The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.

Read the detailed description

This is a randomized,double-blind, paralleled study. Patients will be divided into two groups of experiment and control. All of them will receive core decompression of the femoral head, while experimental group patient will transplant hUC-MSC in addition. Follow-up visit will occur on 1 month, 3 months, and 6 months after operation, and Harris Hip score was applied to evaluate the symptoms change.

Conditions: Osteonecrosis of Femoral Head
Being tested: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#), core decompression
Keywords: Osteonecrosis of Femoral Head, umbilical cord mesenchymal stem cells
Medical subject headings: Femur Head Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)Drug
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2*10^7 cells,
core decompressionProcedure or surgery
The surgery will drill into the femoral neck (hip bone) and through the necrotic area of the bone that died from the lack of blood flow, take out partial osseous tissue.

Study groups in NCT03180463
Study group	Role	What they receive
Group 1	Experimental	Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#). Receives: Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#); Procedure: core decompression
Group 2	Placebo comparator	Core decompression surgery. Receives: Procedure: core decompression

What is being measured

The primary outcome is the main question the study is designed to answer.

MRI imageological examination
MRI imageological examination to evaluate the efficient of mesenchymal stem cells.
Measured: 6 months

Secondary outcomes (1)

Harris Hip Score
Evaluate curative effects by the change of Harris hip score.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202631 Dec 2027

First posted8 Jun 2017
Study start31 Dec 2026 (estimated)
Primary completion30 Jun 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Why it stopped: Others

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteonecrosis of Femoral HeadStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03180463
Sponsor's protocol ID: SCLnow-IMIMH-05
Status last verified: Dec 2025
First submitted: 6 Jun 2017
Last updated: 23 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Active, not recruiting
Avenir Complete Post-Market Clinical Follow-Up Study
Osteoarthritis, Hip, Avascular Necrosis of Hip
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis

All Osteonecrosis of Femoral Head trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
ClinicalTrials.gov ID: NCT03180463
Acronym / sponsor ID: SCLnow-IMIMH-05
Conditions: Osteonecrosis of Femoral Head
Keywords: Osteonecrosis of Femoral Head, umbilical cord mesenchymal stem cells
Phase: Phase 1/2
Study type: Interventional
Recruitment status: SuspendedReason stopped: Others
Enrolment: 30 participants (estimated)
Lead sponsor: Sclnow Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 31 Dec 2026 (estimated)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 8 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Drug: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#), Procedure: core decompressionCore decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
Group 2	Placebo comparator	Procedure: core decompressionCore decompression surgery.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Ficat classification is I, IIa, or IIb period
no obvious improvement or ingravescence by conservative treatment
patients or their statutory receive human umbilical cord mesenchymal stem cell of their own will, and signed informed consent form

Key exclusion criteria (10 listed)

Ficat classification is third or fourth period
acute, chronic infection patients
combined with heart, lung, kidney disease, and cannot tolerate operation
ankylosing spondylitis patient
acetabular dysplasia patient

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2*10^7 cells,	Drug	Group 1
core decompressionThe surgery will drill into the femoral neck (hip bone) and through the necrotic area of the bone that died from the lack of blood flow, take out partial osseous tissue.	Procedure or surgery	Group 1, Group 2

Primary outcome

MRI imageological examination
Time frame: 6 months
MRI imageological examination to evaluate the efficient of mesenchymal stem cells.

1 secondary outcome

Harris Hip Score
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Individual participant dataSharing planned: No

Related trials for Osteonecrosis of Femoral Head

Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Active, not recruiting
Avenir Complete Post-Market Clinical Follow-Up Study
Osteoarthritis, Hip, Avascular Necrosis of Hip
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bahushan study director

Inner Mongolia International Mongolian Hospital

Lei Guo, Dr. study chair

China-Japan Union Hospital, Jilin University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI imageological examination (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03180463.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.