Crohn Disease (CD)REPAIR-pCDNCT07652632
Regenerative Endoscopy in Refractory Perianal Crohn's Disease
A study testing Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection in people with Crohn Disease (CD) and Perianal Crohns Disease, run by Asian Institute of Gastroenterology, India at 2 sites in India.
Trial summary
Perianal fistulizing Crohn's disease (pCD) represents a severe phenotype of Crohn's disease, affecting approximately 20-30% of patients and resulting in chronic drainage, recurrent sepsis, impaired continence, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease (CD), Perianal Crohns Disease
- What is being tested?
- Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesIndia
- Study dates
- 20 Apr 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Crohn's disease with complex perianal fistula (≥1 secondary tract or internal opening involvement)
- Refractory to ≥1 biologic and/or ≥1 prior sphincter sparing procedure
- No abscess on screening MRI
- Mild or no proctitis on endoscopic assessment
- CDAI <220
- Stable IBD therapy ≥8 weeks
- Able to provide informed consent
Who cannot join
- Rectovaginal fistula
- Severe active proctitis requiring urgent escalation
- Malignancy in tract or pelvic region
- Pregnancy or lactation
- ASA IV status or bleeding disorder
- MRI contraindications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
AIG Hospitals
Hyderabad, Telangana, 500032
Rajendra Patel, MBBS, DNB, DrNB, 08152049069, doc.rajendrapatel@gmail.com
Rajendra Patel, MBBS, DNB, DrNB
- Recruiting
AIG Hospitals
Hyderabad, Telangana, 500032
Rajendra Patel, MBBS, DNB, DrNB, +918152049069, doc.rajendrapatel@gmail.com
Rajendra Patel, MBBS, DNB, DrNB
About this study
Official title: Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study
Perianal fistulizing Crohn's disease (pCD) represents a severe phenotype of Crohn's disease, affecting approximately 20-30% of patients and resulting in chronic drainage, recurrent sepsis, impaired continence, and reduced quality of life. Despite optimization of biologics, antibiotics, and surgical drainage, durable healing remains difficult to achieve. Conventional surgical approaches such as curettage or seton management alone yield modest remission rates, and repeated procedures may compromise sphincter integrity.
Autologous mechanically processed tissue stromal vascular fraction (tSVF) is derived from adipose tissue using non enzymatic methods and can be prepared and reinjected during the same operative session. Unlike culture-expanded or enzymatically isolated cell products, mechanical tSVF retains a native adipose micro architecture containing stromal cells, perivascular elements, endothelial progenitors, extracellular matrix components, and bioactive cytokines. This heterogeneous microenvironment is hypothesized to exert immunomodulatory, pro angiogenic, and regenerative effects that may enhance tract healing while preserving sphincter function.
Read more
Mechanical processing avoids enzymatic digestion, cell expansion, and complex laboratory infrastructure, making it potentially more feasible and cost effective in real world settings. However, high quality prospective data evaluating mechanically processed autologous tSVF specifically in refractory complex pCD remain limited, and feasibility data are required before undertaking a large randomized trial.
This single arm pilot feasibility study is therefore designed to evaluate procedural feasibility, safety, and preliminary signals of clinical and radiological healing following mechanical tSVF injection in refractory complex perianal Crohn's disease. The results will inform design parameters, outcome variability, and sample size estimation for a future definitive multicenter trial.
Read the detailed description
All participants receive a single session of autologous mechanical tSVF injection following the standardized standard operating procedure.
- Removal of existing setons where applicable (documented in CRF 3)
- Tumescent liposuction: harvest of 60-120 mL adipose tissue from lower abdomen or flank under tumescent anaesthesia (Klein formula)
- Mechanical emulsification and filtration to obtain tSVF using the specified device and Standard operating procedure - minimum acceptable yield ≥5 mL
- Intraoperative tSVF product quality check: Gram stain from final product; viability assessment by Trypan Blue exclusion where feasible; flow cytometry sample aliquot (sub-study, see Appendix D)
- Fistula preparation: examination under anaesthesia (EUA), curettage of tract, and identification/closure of internal opening
- tSVF injection (6-12 mL total): circumferentially around internal opening region in 0.1-0.3 mL blebs; along tract length avoiding sphincter penetration
- Standard postoperative wound care and antibiotics per unit protocol
- Conditions
- Crohn Disease (CD), Perianal Crohns Disease
- Being tested
- Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection
- Keywords
- tSVF, REPAIR-CD
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) InjectionProcedure or surgery
Autologous adipose tissue harvest by tumescent liposuction followed by same-session mechanical processing to obtain tissue stromal vascular fraction (tSVF) and local injection into the perianal fistula tract and internal opening region
| Study group | Role | What they receive |
|---|---|---|
| Autologous tSVF Injection for Perianal Crohn's Disease | Experimental | Participants with refractory complex perianal fistulizing Crohn's disease will undergo adipose tissue harvesting by tumescent liposuction, mechanical processing to obtain tissue stromal vascular fraction (tSVF), and local injection of tSVF around the internal opening and along the fistula tract, with standard postoperative care and continuation of stable background IBD therapy. Receives: Procedure: Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Preliminary Efficacy at Week 24
•Assess feasibility (recruitment rate, retention to Week 24, protocol adherence, and tSVF processing success rate) and generate preliminary efficacy estimates for mechanical tSVF injection in refractory complex pCD.
Measured: Week 24
Secondary outcomes (1)
Cessation of fistula drainage
- Time to cessation of drainage
- Change in Perianal Disease Activity Index (PDAI) from baseline
- MRI tract volume and signal intensity changes (quantified centrally)
- Vaizey continence score change
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) change
- Recurrence and fistula related interventions
- Safety: procedure related and systemic adverse events
Measured: Week 24 & 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start20 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Arm Prospective Feasibility Study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Rajendra Patel, MBBS, DNB, DrNB, Principal investigator, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652632
- Sponsor's protocol ID
- tSVF 1
- Acronym
- REPAIR-pCD
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital policy
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07652632
- Acronym / sponsor ID
- REPAIR-pCD / tSVF 1
- Conditions
- Crohn Disease (CD), Perianal Crohns Disease
- Keywords
- tSVF, REPAIR-CD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Jun 2026 (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.
Perianal fistulizing Crohn's disease (pCD) represents a severe phenotype of Crohn's disease, affecting approximately 20-30% of patients and resulting in chronic drainage, recurrent sepsis, impaired continence, and reduced quality of life. Despite optimization of biologics, antibiotics, and surgical drainage, durable healing remains difficult to achieve. Conventional surgical approaches such as curettage or seton management alone yield modest remission rates, and repeated procedures may compromise sphincter integrity.
Autologous mechanically processed tissue stromal vascular fraction (tSVF) is derived from adipose tissue using non enzymatic methods and can be prepared and reinjected during the same operative session. Unlike culture-expanded or enzymatically isolated cell products, mechanical tSVF retains a native adipose micro architecture containing stromal cells, perivascular elements, endothelial progenitors, extracellular matrix components, and bioactive cytokines. This heterogeneous microenvironment is hypothesized to exert immunomodulatory, pro angiogenic, and regenerative effects that may enhance tract healing while preserving sphincter function.
Mechanical processing avoids enzymatic digestion, cell expansion, and complex laboratory infrastructure, making it potentially more feasible and cost effective in real world settings. However, high quality prospective data evaluating mechanically processed autologous tSVF specifically in refractory complex pCD remain limited, and feasibility data are required before undertaking a large randomized trial.
This single arm pilot feasibility study is therefore designed to evaluate procedural feasibility, safety, and preliminary signals of clinical and radiological healing following mechanical tSVF injection in refractory complex perianal Crohn's disease. The results will inform design parameters, outcome variability, and sample size estimation for a future definitive multicenter trial.
Detailed description
All participants receive a single session of autologous mechanical tSVF injection following the standardized standard operating procedure.
- Removal of existing setons where applicable (documented in CRF 3)
- Tumescent liposuction: harvest of 60-120 mL adipose tissue from lower abdomen or flank under tumescent anaesthesia (Klein formula)
- Mechanical emulsification and filtration to obtain tSVF using the specified device and Standard operating procedure - minimum acceptable yield ≥5 mL
- Intraoperative tSVF product quality check: Gram stain from final product; viability assessment by Trypan Blue exclusion where feasible; flow cytometry sample aliquot (sub-study, see Appendix D)
- Fistula preparation: examination under anaesthesia (EUA), curettage of tract, and identification/closure of internal opening
- tSVF injection (6-12 mL total): circumferentially around internal opening region in 0.1-0.3 mL blebs; along tract length avoiding sphincter penetration
- Standard postoperative wound care and antibiotics per unit protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Arm Prospective Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| Autologous tSVF Injection for Perianal Crohn's Disease | Experimental | Procedure: Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) InjectionParticipants with refractory complex perianal fistulizing Crohn's disease will undergo adipose tissue harvesting by tumescent liposuction, mechanical processing to obtain tissue stromal vascular fraction (tSVF), and local injection of tSVF around the internal opening and along the fistula tract, with standard postoperative care and continuation of stable background IBD therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65 years
- Crohn's disease with complex perianal fistula (≥1 secondary tract or internal opening involvement)
- Refractory to ≥1 biologic and/or ≥1 prior sphincter sparing procedure
- No abscess on screening MRI
- Mild or no proctitis on endoscopic assessment
Key exclusion criteria (6 listed)
- Rectovaginal fistula
- Severe active proctitis requiring urgent escalation
- Malignancy in tract or pelvic region
- Pregnancy or lactation
- ASA IV status or bleeding 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 |
|---|---|---|
| Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) InjectionAutologous adipose tissue harvest by tumescent liposuction followed by same-session mechanical processing to obtain tissue stromal vascular fraction (tSVF) and local injection into the perianal fistula tract and internal opening region | Procedure or surgery | Autologous tSVF Injection for Perianal Crohn's Disease |
Primary outcome
Feasibility and Preliminary Efficacy at Week 24
Time frame: Week 24
•Assess feasibility (recruitment rate, retention to Week 24, protocol adherence, and tSVF processing success rate) and generate preliminary efficacy estimates for mechanical tSVF injection in refractory complex pCD.
1 secondary outcome
Cessation of fistula drainage
Time frame: Week 24 & 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Hospital policy
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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.
Rajendra Patel, MBBS, DNB, DrNB principal investigator
AIG Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection in people with Crohn Disease (CD) and Perianal Crohns Disease, run by Asian Institute of Gastroenterology, India at 2 sites in India.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajendra Patel, MBBS, DNB, DrNB (+918152049069, doc.rajendrapatel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Preliminary Efficacy at Week 24 (time frame: Week 24). 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 17 Jun 2026.