OsteoarthritisPhase 1NCT03089762
Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
A Phase 1 study testing Intra-articular injection of SVF plus PRP in people with Osteoarthritis, run by Bioheart, Inc..
Trial summary
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Intra-articular injection of SVF plus PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 12 Feb 2012to 30 Dec 2014
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients age 50 or older who present with symptomatic primary osteoarthritis of the knee
- daily pain for the previous 3 months
- analgesics usage at least once a week
- less than 30 minutes of morning stiffness
- WOMAC score of ≤ 75 in the target knee
- Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2
Who cannot join
- evidence of secondary knee osteoarthritis
- severe osteoarthritis (Joint space width - JSW < 2 mm)
- prior intra articular injections within the previous one year prior to inclusion
- patients with clinically significant systemic disease
About this study
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.
- Conditions
- Osteoarthritis
- Being tested
- Intra-articular injection of SVF plus PRP
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injection of SVF plus PRPBiological
administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| SVF and PRP | Experimental | Not described Receives: Biological: Intra-articular injection of SVF plus PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC (Western Ontario and McMaster Universities Arthritis Index)
Measured: 1 year
Secondary outcomes (1)
Six minute walk distance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start12 Feb 2012
- Primary completion30 Dec 2014
- Study completion30 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Bioheart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anupam Hospital, RegennMed Research and Therapeutics Delhi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089762
- Sponsor's protocol ID
- AAH/02/12
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bansal H, Comella K, Leon J, Verma P, Agrawal D, Koka P, Ichim T. Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis. J Transl Med. 2017 Jun 19;15(1):141. doi: 10.1186/s12967-017-1242-4.
PubMed 28629466
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
- ClinicalTrials.gov ID
- NCT03089762
- Acronym / sponsor ID
- AAH/02/12
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bioheart, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Anupam Hospital, RegennMed Research and Therapeutics Delhi
- Study start
- 12 Feb 2012 (actual)
- Primary completion
- 30 Dec 2014 (actual)
- Study completion
- 30 Dec 2014 (actual)
- First posted
- 24 Mar 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.
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SVF and PRP | Experimental | Biological: Intra-articular injection of SVF plus PRP |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients age 50 or older who present with symptomatic primary osteoarthritis of the knee
- daily pain for the previous 3 months
- analgesics usage at least once a week
- less than 30 minutes of morning stiffness
- WOMAC score of ≤ 75 in the target knee
Key exclusion criteria (4 listed)
- evidence of secondary knee osteoarthritis
- severe osteoarthritis (Joint space width - JSW < 2 mm)
- prior intra articular injections within the previous one year prior to inclusion
- patients with clinically significant systemic disease
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 |
|---|---|---|
| Intra-articular injection of SVF plus PRPadministering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2 | Biological | SVF and PRP |
Primary outcome
WOMAC (Western Ontario and McMaster Universities Arthritis Index)
Time frame: 1 year
1 secondary outcome
Six minute walk distance
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Derived from this study: PubMed 28629466Bansal H, Comella K, Leon J, Verma P, Agrawal D, Koka P, Ichim T. Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis. J Transl Med. 2017 Jun 19;15(1):141. doi: 10.1186/s12967-017-1242-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intra-articular injection of SVF plus PRP in people with Osteoarthritis, run by Bioheart, Inc..
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WOMAC (Western Ontario and McMaster Universities Arthritis Index) (time frame: 1 year). 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 NCT03089762, which also lists 1 linked publication.
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 27 Mar 2017.