Abnormally Healing WoundsPhase 1NCT02590042
Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction
A Phase 1 study testing ADSC-SVF-002 in people with Abnormally Healing Wounds and Scars, run by AdiSave Inc. at 1 site in Canada.
Trial summary
A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing stromal vascular fraction (SVF) obtained from subcutaneous fat harvested by liposuction from a patient. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormally Healing Wounds, Scars, Soft Tissue Defects
- What is being tested?
- ADSC-SVF-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2017to Jan 2021
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has soft tissue deficiencies, soft tissue post traumatic malformations, scars, and/or abnormal wound healing.
- Subject is an adult male or non-pregnant female between the ages of 18 to 80 years.
- Subject is able to undergo a liposuction procedure in the opinion of the investigator or per facility guidelines.
- Subject is able to read, understand and sign a written Informed Consent to participate in the study.
- Subject is willing and able to comply with the study protocol, including requirements for taking and abstaining from medications.
Who cannot join
- The subject is a woman of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history), but is not using a highly effective method of contraception [oral, injected or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; or male sterilization (vasectomy)].
- Subject has a history of cancer and/or any known conditions/diseases prone to malignancy.
- Subject has significant cardiac, renal, or hepatic failure or any other disease that may interfere with the ability to interpret the results of the study.
- Subject has an infection, cellulitis, or osteomyelitis diagnosed by MRI and microbiologic culture results.
- Subject has an autoimmune disorder.
- Subject has a connective, metabolic or atrophic skin disease.
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- Subject is under chronic anticoagulant therapy.
- Subject has a Body Mass Index (BMI) >30.
- Subject is positive for HBs antigen, HCV antibody, or HIV antibody.
- Subject has received other investigational drug/drugs or unapproved medication within 3 months before registration in this study.
- Subject has a history of hematopoietic stem cell transplantation or radio immunotherapy.
- Subject has a recent and significant weight loss, the cause of which has not been determined.
- Subject has a history of hereditary linked malignancy in a first-degree relative (parent, child, sibling).
- Subject is participating in another clinical trial within 6 weeks prior to registration in this study.
- Subject has a psychiatric disorder that in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Forest Hill Institute of Aesthetic Plastic Surgery
Toronto, Ontario, M6C2E3
Sarah HM Wong, MD, 416-289-3200, drsarahwong@gmail.com
About this study
Official title: A Phase I Open-labeled, Single-arm, Single-centred Study to Test the Safety of ADSC-SVF-002 in Subjects With Soft Tissue Defects or Abnormal Wound Healing
A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing stromal vascular fraction (SVF) obtained from subcutaneous fat harvested by liposuction from a patient. As a cellular therapy product, ADSC-SVF-002 (fresh or cryopreserved) will be administered subcutaneously via injection, with or without unprocessed autologous fat (fresh or cryopreserved), into soft tissue defects and abnormally healing wounds. The primary objective of the trial is to demonstrate the safety of ADSC-SVF-002 in a population of subjects with soft tissue defects or abnormal wound healing who are still symptomatic despite being managed by conventional therapies.
Read the detailed description
Protocol Number: SJS-CT-001 Phase: Pilot study Methodology: Open label, single-arm Study Duration: Six months after accrual and treatment of the last patient Study Center(s): Single-center Objectives: To demonstrate the safety of subcutaneous administration of autologous ADSC-SVF-002 in a population of subjects with soft tissue defects or abnormal wound healing who are still symptomatic despite being managed by conventional therapies.
Number of Subjects: 10 Diagnosis and Main Inclusion Criteria: Subject has soft tissue deficiencies, soft tissue post traumatic malformations, scars, and/or abnormal wound healing.
Study Product, Dose, Route, Regimen: ADSC-SVF-002. 1.0x106 cells/mL defect (when administered without fat) to 1.2x106 cells/mL defect (when administered with fat). Subcutaneous injection.
Duration of administration: Administration of the product takes approximately 30 minutes. Administered once.
Reference therapy: N/A
Statistical Methodology: Safety outcomes will be reported with descriptive statistics. Secondary (efficacy) outcomes will be assessed relative to baseline (screening) as follows:
- For outcomes assessed at multiple follow-up visits, one-way ANOVAs followed by the Tukey's test will be conducted
- For outcomes assessed at one follow-up visit, a Student's t-test will be conducted.
Data will be reported as mean ± SD and p<0.05 will be considered significant.
- Conditions
- Abnormally Healing Wounds, Scars, Soft Tissue Defects
- Being tested
- ADSC-SVF-002
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSC-SVF-002Biological
Also called ADSC-SVF manufactured by AdiSave
ADSC-SVF with the following identity:
Less than or equal to 10% each CD34 and CD45 positive cells At least 70% each CD90, CD73 and CD105 positive cells Viability of at least 85% Mean Florescence Intensity of less than or equal to 100 C12FDG 0-5-2.5x10^6 cells/g of liposuctioned (hydrated fat)
| Study group | Role | What they receive |
|---|---|---|
| ADSC-SVF-002 | Experimental | Cells will be administered at 1x10^6 cells/mL of defect. If administered with fat, the cells will be administered at 1.2x10^6 cells/mL of defect. Receives: Biological: ADSC-SVF-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous monitoring of safety via laboratory tests and physical examinations
Continuous monitoring of safety as requested by Health Canada
Measured: Screening, 48 hours after procedure, and at post-treatment months 1, 2 and 6
Secondary outcomes (2)
Physician satisfaction with wound cosmesis, assessed using the Hollander Wound Evaluation Scale
Measured: Screening, 48 hours after procedure, and at post-treatment day 10 and months 1-6
Patient satisfaction with wound cosmesis, assessed using the 100 mm vertical line visual analogue scale
Measured: Screening, 48 hours after procedure, and at post-treatment day 10 and months 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2017 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormally Healing WoundsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdiSave Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah HM Wong, MD, Principal investigator, Forest Hill Institute of Aesthetic Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590042
- Sponsor's protocol ID
- SJS-CT-001
- Status last verified
- Jul 2017
- First submitted
- 21 Oct 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-labeled, Single-arm, Single-centred Study to Test the Safety of ADSC-SVF-002 in Subjects With Soft Tissue Defects or Abnormal Wound Healing
- ClinicalTrials.gov ID
- NCT02590042
- Acronym / sponsor ID
- SJS-CT-001
- Conditions
- Abnormally Healing Wounds, Scars, Soft Tissue Defects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- AdiSave Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2017 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- 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.
A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing stromal vascular fraction (SVF) obtained from subcutaneous fat harvested by liposuction from a patient. As a cellular therapy product, ADSC-SVF-002 (fresh or cryopreserved) will be administered subcutaneously via injection, with or without unprocessed autologous fat (fresh or cryopreserved), into soft tissue defects and abnormally healing wounds. The primary objective of the trial is to demonstrate the safety of ADSC-SVF-002 in a population of subjects with soft tissue defects or abnormal wound healing who are still symptomatic despite being managed by conventional therapies.
Detailed description
Protocol Number: SJS-CT-001 Phase: Pilot study Methodology: Open label, single-arm Study Duration: Six months after accrual and treatment of the last patient Study Center(s): Single-center Objectives: To demonstrate the safety of subcutaneous administration of autologous ADSC-SVF-002 in a population of subjects with soft tissue defects or abnormal wound healing who are still symptomatic despite being managed by conventional therapies.
Number of Subjects: 10 Diagnosis and Main Inclusion Criteria: Subject has soft tissue deficiencies, soft tissue post traumatic malformations, scars, and/or abnormal wound healing.
Study Product, Dose, Route, Regimen: ADSC-SVF-002. 1.0x106 cells/mL defect (when administered without fat) to 1.2x106 cells/mL defect (when administered with fat). Subcutaneous injection.
Duration of administration: Administration of the product takes approximately 30 minutes. Administered once.
Reference therapy: N/A
Statistical Methodology: Safety outcomes will be reported with descriptive statistics. Secondary (efficacy) outcomes will be assessed relative to baseline (screening) as follows:
- For outcomes assessed at multiple follow-up visits, one-way ANOVAs followed by the Tukey's test will be conducted
- For outcomes assessed at one follow-up visit, a Student's t-test will be conducted.
Data will be reported as mean ± SD and p<0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADSC-SVF-002 | Experimental | Biological: ADSC-SVF-002Cells will be administered at 1x10^6 cells/mL of defect. If administered with fat, the cells will be administered at 1.2x10^6 cells/mL of defect. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has soft tissue deficiencies, soft tissue post traumatic malformations, scars, and/or abnormal wound healing.
- Subject is an adult male or non-pregnant female between the ages of 18 to 80 years.
- Subject is able to undergo a liposuction procedure in the opinion of the investigator or per facility guidelines.
- Subject is able to read, understand and sign a written Informed Consent to participate in the study.
- Subject is willing and able to comply with the study protocol, including requirements for taking and abstaining from medications.
Key exclusion criteria (15 listed)
- The subject is a woman of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history), but is not using a highly effective method of contraception [oral, injected or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; or male sterilization (vasectomy)].
- Subject has a history of cancer and/or any known conditions/diseases prone to malignancy.
- Subject has significant cardiac, renal, or hepatic failure or any other disease that may interfere with the ability to interpret the results of the study.
- Subject has an infection, cellulitis, or osteomyelitis diagnosed by MRI and microbiologic culture results.
- Subject has an autoimmune disorder.
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 |
|---|---|---|
| ADSC-SVF-002Also: ADSC-SVF manufactured by AdiSaveADSC-SVF with the following identity: Less than or equal to 10% each CD34 and CD45 positive cells At least 70% each CD90, CD73 and CD105 positive cells Viability of at least 85% Mean Florescence Intensity of less than or equal to 100 C12FDG 0-5-2.5x10^6 cells/g of liposuctioned (hydrated fat) | Biological | ADSC-SVF-002 |
Primary outcome
Continuous monitoring of safety via laboratory tests and physical examinations
Time frame: Screening, 48 hours after procedure, and at post-treatment months 1, 2 and 6
Continuous monitoring of safety as requested by Health Canada
2 secondary outcomes
Physician satisfaction with wound cosmesis, assessed using the Hollander Wound Evaluation Scale
Time frame: Screening, 48 hours after procedure, and at post-treatment day 10 and months 1-6
Patient satisfaction with wound cosmesis, assessed using the 100 mm vertical line visual analogue scale
Time frame: Screening, 48 hours after procedure, and at post-treatment day 10 and months 1-6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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.
Sarah HM Wong, MD principal investigator
Forest Hill Institute of Aesthetic Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADSC-SVF-002 in people with Abnormally Healing Wounds and Scars, run by AdiSave Inc. at 1 site in Canada.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Jul 2017. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Contact Keren Leibson, PhD (416 785-7536, info@adisave.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous monitoring of safety via laboratory tests and physical examinations (time frame: Screening, 48 hours after procedure, and at post-treatment months 1, 2 and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2017.