Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions

NCT ID: NCT01953523

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-02

Study Completion Date

2017-01-01

Brief Summary

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To evaluate for any adverse effects that may be related to the administration and reception of autologous adipose derived stromal vascular fraction (SVF). Secondarily, the study monitors the results of subjective and objective findings as it applies to the non-blinded deployment of autologous SVF for various inflammatory and/or degenerative conditions including select orthopedic, neurologic, urologic and cardio-pulmonary conditions. SVF deployments include intra-venous, intra-articular, and soft tissue injections.

Detailed Description

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SVF Stromal Vascular Fraction is obtained by lipoharvesting, procurement, and lipo-transfer as a same day operative procedure

Conditions

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Neurodegenerative Diseases Osteoarthritis Erectile Dysfunction Autoimmune Diseases Cardiomyopathies Emphysema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deployment of stromal vascular fraction

Administration of autologous adipose derived SVF

Group Type EXPERIMENTAL

Administration of autologous adipose derived SVF

Intervention Type PROCEDURE

Intra-venous, intra-articular, and soft tissue injection delivery of SVF

Interventions

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Administration of autologous adipose derived SVF

Intra-venous, intra-articular, and soft tissue injection delivery of SVF

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient must be age 16 or older
* Patient must have a degenerative disease or inflammatory disease that meets criteria for treatment under the IRB which includes: Arthritis, Auto-immune disease,COPD, Cardiomyopathy, Peyronies Disease,Interstitial Cystitis, Erectile Dysfunction, and Neurodegenerative disease such as Parkinsons, ALS, Neuropathy.
* Patient must be healthy enough to tolerate a local anesthetic

Exclusion Criteria

* Patient must not have active cancer
* Patient must not have active infection
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elliot Lander

INDUSTRY

Sponsor Role lead

Responsible Party

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Elliot Lander

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mark H Berman, MD

Role: PRINCIPAL_INVESTIGATOR

Cell surgical network

Locations

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California Stem Cell Treatment Center

Rancho Mirage, California, United States

Site Status

Countries

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United States

References

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Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available.

Reference Type DERIVED
PMID: 25974235 (View on PubMed)

Related Links

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Other Identifiers

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CSN111

Identifier Type: -

Identifier Source: org_study_id

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